Incident: Quality Issues in EpiPen Manufacturing at Meridian Medical Technologies

Published Date: 2019-03-01

Postmortem Analysis
Timeline 1. The software failure incident involving quality issues with the manufacture of auto-injectors at Meridian Medical Technologies, a unit of Pfizer, happened before the article was published on March 1, 2019 [81017]. Therefore, the timeline of the software failure incident is unknown based on the information provided in the article.
System unknown
Responsible Organization 1. Meridian Medical Technologies, a unit of Pfizer, was responsible for causing the software failure incident related to quality issues involving the manufacture of EpiPen auto-injectors [81017].
Impacted Organization 1. Severe allergy sufferers who rely on EpiPen auto-injectors [81017]
Software Causes 1. Unknown
Non-software Causes 1. Manufacturing problems at the Meridian Medical Technologies site, a unit of Pfizer, which produces EpiPen injectors [81017]. 2. Failure to thoroughly investigate product failures, including EpiPen products associated with patient deaths and severe illnesses, as highlighted by the Food and Drug Administration [81017].
Impacts 1. The software failure incident involving quality issues in the manufacture of EpiPen auto-injectors at Pfizer's Meridian Medical Technologies site led to the recall of tens of thousands of devices by Mylan NV due to complaints of some EpiPens failing to activate [81017].
Preventions 1. Implementing a robust quality control system during the manufacturing process to detect and address any defects or malfunctions in the auto-injectors [81017]. 2. Conducting thorough investigations into product failures, including failures associated with patient deaths and severe illnesses, to identify and rectify issues promptly [81017]. 3. Taking corrective actions promptly based on FDA inspections and warnings to ensure the safety and effectiveness of the EpiPen auto-injectors [81017].
Fixes 1. Conducting a thorough investigation into the manufacturing problems at Meridian Medical Technologies site to identify the root causes of the quality issues involving the manufacture of auto-injectors [Article 81017]. 2. Implementing corrective actions based on the findings of the investigation to address the failures associated with EpiPen products, including those linked to patient deaths and severe illnesses [Article 81017]. 3. Enhancing the quality control processes and procedures at the plant near St. Louis, Missouri, where all EpiPens are produced, to prevent future incidents of device failures [Article 81017].
References 1. U.S. Attorney's office for the Southern District of New York 2. Pfizer Inc 3. Food and Drug Administration (FDA) 4. Meridian Medical Technologies 5. Mylan NV pharmaceutical company 6. Reuters 7. Akanksha Rana

Software Taxonomy of Faults

Category Option Rationale
Recurring one_organization (a) The software failure incident having happened again at one_organization: The article mentions that Meridian Medical Technologies, a unit of Pfizer, has been hit by a series of manufacturing problems in recent years related to the manufacture of EpiPen injectors. The FDA had issued a warning letter to Meridian in 2017, stating that the company had failed to thoroughly investigate product failures, including EpiPen products associated with patient deaths and severe illnesses. This indicates a recurring issue within the same organization [81017]. (b) The software failure incident having happened again at multiple_organization: There is no specific mention in the article about similar incidents happening at other organizations or with their products and services.
Phase (Design/Operation) operation (a) The article does not mention any specific software failure incident related to the design phase of development. (b) The article mentions quality issues involving the manufacture of auto-injectors at Pfizer's Meridian Medical Technologies site, which is a unit of Pfizer that manufactures EpiPen injectors. The manufacturing problems at Meridian have led to recalls of EpiPens due to complaints that some devices had failed to activate. This can be considered a failure related to the operation phase, specifically due to issues introduced during the manufacturing process [81017].
Boundary (Internal/External) within_system, outside_system The software failure incident related to the EpiPen auto-injectors manufactured by Mylan NV at the Meridian Medical Technologies site can be attributed to factors both within and outside the system. (a) within_system: The failure within the system can be linked to manufacturing problems at the Meridian Medical Technologies site, a unit of Pfizer. The FDA had issued a warning letter to Meridian in 2017, citing failures to thoroughly investigate product failures, including EpiPen products associated with patient deaths and severe illnesses. The company's lack of corrective actions until after FDA inspections indicates internal issues contributing to the software failure incident [81017]. (b) outside_system: The failure outside the system can be associated with quality issues involving the manufacture of auto-injectors at the Meridian Medical Technologies site. Pfizer received a request for documents as part of a U.S. investigation related to these quality issues, indicating external factors impacting the software failure incident [81017].
Nature (Human/Non-human) human_actions (a) The software failure incident related to non-human actions: The article does not mention any specific software failure incident caused by non-human actions. It primarily focuses on quality issues involving the manufacture of auto-injectors at Pfizer's Meridian Medical Technologies site, leading to EpiPen product failures and recalls. (b) The software failure incident related to human actions: The article highlights that Meridian, a unit of Pfizer, had manufacturing problems and quality issues with EpiPen injectors. It mentions that the FDA had criticized Meridian for failing to thoroughly investigate product failures, including EpiPen products associated with patient deaths and severe illnesses. The FDA also noted that the company failed to take corrective actions until after FDA's inspection, indicating human actions contributing to the software failure incident [81017].
Dimension (Hardware/Software) software (a) The articles do not mention any hardware-related failures that contributed to the software failure incident. (b) The software failure incident at Meridian Medical Technologies, a unit of Pfizer, was related to quality issues involving the manufacture of auto-injectors, specifically EpiPen injectors used to deliver an emergency allergy antidote. The FDA had issued a warning letter to Meridian in 2017, stating that the company had failed to thoroughly investigate product failures, including EpiPen products associated with patient deaths and severe illnesses. This failure to investigate and take corrective actions was a software-related issue originating in the manufacturing process of the auto-injectors [81017].
Objective (Malicious/Non-malicious) non-malicious (a) The software failure incident related to the EpiPen auto-injectors was non-malicious. The failure was attributed to quality issues involving the manufacture of the auto-injectors at Pfizer's Meridian Medical Technologies site. The article mentions that Meridian, a unit of Pfizer, had been facing manufacturing problems, including issues with EpiPen injectors failing to activate, leading to recalls. The FDA had also criticized Meridian for failing to thoroughly investigate product failures, including incidents associated with patient deaths and severe illnesses, indicating unintentional quality issues rather than malicious intent [81017].
Intent (Poor/Accidental Decisions) unknown The articles do not mention any software failure incident related to poor or accidental decisions. Therefore, the intent of the software failure incident in this case is unknown.
Capability (Incompetence/Accidental) unknown The articles do not mention any software failure incident related to development incompetence or accidental factors. Therefore, the information regarding these specific types of software failure incidents is unknown based on the provided articles.
Duration unknown The articles do not mention any specific software failure incident related to the EpiPen manufacturing issues at Meridian Medical Technologies. Therefore, the duration of the software failure incident, whether permanent or temporary, is unknown.
Behaviour unknown (a) crash: The article does not mention a specific software crash incident related to the EpiPen auto-injectors manufactured by Mylan NV at the Meridian Medical Technologies site [81017]. (b) omission: The article does not mention a specific software omission incident related to the EpiPen auto-injectors manufactured by Mylan NV at the Meridian Medical Technologies site [81017]. (c) timing: The article does not mention a specific software timing incident related to the EpiPen auto-injectors manufactured by Mylan NV at the Meridian Medical Technologies site [81017]. (d) value: The article does not mention a specific software value incident related to the EpiPen auto-injectors manufactured by Mylan NV at the Meridian Medical Technologies site [81017]. (e) byzantine: The article does not mention a specific software byzantine incident related to the EpiPen auto-injectors manufactured by Mylan NV at the Meridian Medical Technologies site [81017]. (f) other: The article does not specify any other behavior of the software failure incident related to the EpiPen auto-injectors manufactured by Mylan NV at the Meridian Medical Technologies site [81017].

IoT System Layer

Layer Option Rationale
Perception None None
Communication None None
Application None None

Other Details

Category Option Rationale
Consequence death, harm (a) death: People lost their lives due to the software failure The article mentions that the FDA had criticized Meridian for failing to thoroughly investigate product failures, including EpiPen products associated with patient deaths and severe illnesses. It stated that the company did not take corrective actions until after the FDA's inspection [81017].
Domain manufacturing, health (a) The failed system in the incident was related to the health industry. The software failure incident involved the manufacture of auto-injectors, specifically EpiPen injectors used to deliver an emergency allergy antidote [Article 81017]. The manufacturing problems at the Meridian Medical Technologies site, a unit of Pfizer, which produces EpiPens, led to quality issues and recalls of the devices due to complaints that some had failed to activate. The FDA had also raised concerns about product failures associated with patient deaths and severe illnesses, indicating a significant impact on the health industry.

Sources

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