| Recurring |
one_organization |
(a) The software failure incident related to cybersecurity risks in insulin pumps has happened again within the same organization, Medtronic. The FDA issued a warning about potential hacking risks for certain insulin pumps from Medtronic MiniMed, leading to a recall of these devices due to cybersecurity vulnerabilities [85973]. Medtronic is providing alternative insulin pumps with enhanced built-in cybersecurity capabilities to address this issue. |
| Phase (Design/Operation) |
design, operation |
(a) The software failure incident in this case is related to the design phase. The issue with the insulin pumps from Medtronic MiniMed was due to potential cybersecurity risks, which were introduced during the development of the devices. The FDA warned about the risk of hacking into the devices wirelessly, indicating a vulnerability in the design of the software that could allow unauthorized access and manipulation of the pump's settings [85973].
(b) Additionally, the software failure incident can also be linked to the operation phase. The FDA advised patients to take precautions to minimize the potential risk of a cybersecurity attack while waiting for a replacement pump, suggesting that the operation or use of the devices could also contribute to the failure or exploitation of the vulnerability [85973]. |
| Boundary (Internal/External) |
within_system |
(a) within_system: The software failure incident related to the insulin pumps from Medtronic MiniMed was due to potential cybersecurity risks. The FDA warned about the risk of hacking into the devices, where a hacker could change the pump's settings to over-deliver insulin or stop insulin delivery altogether, posing significant risks to patients [85973]. The vulnerability was within the system of the insulin pumps, making them susceptible to unauthorized access and manipulation. |
| Nature (Human/Non-human) |
non-human_actions |
(a) The software failure incident in this case is related to non-human actions, specifically cybersecurity risks and vulnerabilities in certain insulin pumps from Medtronic MiniMed. The FDA warned about the potential risk of hacking for these insulin pumps, where someone nearby could connect wirelessly and potentially hack into the devices to change settings, leading to dangerous outcomes for diabetes patients [85973]. |
| Dimension (Hardware/Software) |
hardware, software |
(a) The software failure incident related to hardware:
The software failure incident reported in the article is due to potential cybersecurity risks associated with certain insulin pumps from Medtronic MiniMed. The FDA warned about the risk of hacking for some diabetes patients' insulin pumps, indicating that the vulnerability lies in the hardware of the insulin pumps [85973].
(b) The software failure incident related to software:
The software failure incident is primarily attributed to software vulnerabilities in the insulin pumps. The FDA mentioned that the hacker could potentially change the pump's settings through wireless connections, leading to dangerous outcomes for patients. Medtronic is recalling specific models of insulin pumps due to software vulnerabilities that could be exploited by unauthorized users [85973]. |
| Objective (Malicious/Non-malicious) |
malicious |
(a) The software failure incident related to the insulin pumps from Medtronic MiniMed was malicious in nature. The FDA warned about the potential risk of hacking for some diabetes patients' insulin pumps, highlighting the cybersecurity vulnerability that could allow unauthorized users to connect wirelessly and potentially hack into the devices. This could lead to dangerous outcomes such as over-delivering insulin or stopping insulin delivery, posing significant risks to patients' health [85973]. |
| Intent (Poor/Accidental Decisions) |
unknown |
(a) The intent of the software failure incident was not due to poor decisions but rather due to cybersecurity vulnerabilities that could potentially be exploited by unauthorized users. The FDA urged manufacturers to remain vigilant about their medical products, monitor and assess cybersecurity vulnerability risks, and be proactive about disclosing vulnerabilities and mitigations to address them [85973]. |
| Capability (Incompetence/Accidental) |
development_incompetence |
(a) The software failure incident related to development incompetence is evident in the case of the insulin pumps from Medtronic MiniMed. The FDA issued a warning about potential cybersecurity risks with certain insulin pumps, leading to a recall of these devices due to the risk of hacking. The vulnerability in the software of these insulin pumps allowed for the possibility of unauthorized users nearby to wirelessly connect and potentially hack into the devices, posing serious risks to patients using them [85973]. This incident highlights the importance of professional competence in developing secure medical devices to prevent such cybersecurity vulnerabilities. |
| Duration |
temporary |
The software failure incident related to the insulin pumps from Medtronic MiniMed is temporary. The FDA issued a warning about potential cybersecurity risks with certain insulin pumps, leading to a recall of the affected models. Medtronic is providing alternative insulin pumps with enhanced built-in cybersecurity capabilities to replace the vulnerable ones [85973]. This indicates that the failure is temporary and can be mitigated by replacing the affected devices with more secure alternatives. |
| Behaviour |
value, other |
(a) crash: The software failure incident in this case is not described as a crash where the system loses state and does not perform any of its intended functions. The issue with the insulin pumps from Medtronic MiniMed is related to potential cybersecurity risks and the risk of hacking into the devices, which could lead to unauthorized changes in the pump's settings [85973].
(b) omission: The software failure incident is not described as an omission where the system omits to perform its intended functions at an instance(s). Instead, the concern is about potential unauthorized access and changes to the insulin pump settings due to cybersecurity vulnerabilities [85973].
(c) timing: The software failure incident is not related to timing issues where the system performs its intended functions correctly but too late or too early. The main issue highlighted is the potential risk of hacking into the insulin pumps and making unauthorized changes to the pump settings [85973].
(d) value: The software failure incident is related to the system performing its intended functions incorrectly. The concern is that a hacker could potentially change the pump's settings to either over-deliver insulin, leading to low blood sugar, or stop insulin delivery altogether, leading to high blood sugar and diabetic ketoacidosis [85973].
(e) byzantine: The software failure incident is not described as a byzantine failure where the system behaves erroneously with inconsistent responses and interactions. The main issue is the cybersecurity vulnerability that could allow unauthorized access to the insulin pumps and potentially harmful changes to the pump settings [85973].
(f) other: The software failure incident in this case involves a potential cybersecurity risk where unauthorized users could exploit vulnerabilities in the insulin pumps to make harmful changes to the pump settings. The FDA has issued a warning about the risk of hacking into certain insulin pumps from Medtronic MiniMed, leading to concerns about patient safety and the need to switch to more secure pump models [85973]. |