Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Hyperglycemia (1905); Blurred Vision (2137); Hot Flashes/Flushes (2153); Numbness (2415); Loss of consciousness (2418); Shaking/Tremors (2515)
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Event Date 02/08/2024 |
Event Type
Injury
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Manufacturer Narrative
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The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.Sensor kit expiration date is (b)(6) 2024.The medical event associated with this case occurred on (b)(6) 2024 which confirms the usage of the device beyond the useful life of the device.No additional investigation are required as the device met its specification lifespan.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A low readings issue with the adc device was reported.The customer reported to have received a low sensor scan result of 52 mg/dl compared to a 370 mg/dl reading obtained on a healthcare professional (hcp) brand device and the results, when plotted on a parkes error grid, fall into the "d" zone, showing the difference in values to be clinically significant.As a result, the customer experienced a loss of consciousness, hot flashes, blurred vision, anxiety, heart palpitations, numb legs, shivers and was unable to self-treat.The customer had contact with an emergency doctor who was reported to have administered 16 iu of humalog, obtained unspecified blood testing and ordered an electrocardiogram for the treatment of hyperglycemia.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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