Model Number 71733-01 |
Device Problems
Device Alarm System (1012); Unable to Obtain Readings (1516)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 03/02/2024 |
Event Type
Injury
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Event Description
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An alarm issue was reported with the adc device in use with an iphone 11 with ios operating system version 17.2.1.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced shaking, sweating, feeling bad, laziness and was unable to self-treat, requiring treatment of juice by third-party.There was no report of death or permanent impairment associated with this event.
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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.At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.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.The customer reported having signal loss.Adc attempted to replicate the reported issue and the reported configuration of ios 17.2.1 is not compatible with the freestyle librelink application.The compatibility guide is available to the customer on the abbott diabetes care website.All pertinent information available to abbott diabetes care has been submitted.
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Manufacturer Narrative
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Sensor (b)(6)has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The sensor was activated with a known good reader and the bluetooth connection was successful.A linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), and signal loss message was observed.Sensor was scanned with reader to re-establish bluetooth connection and then was placed at a distance from the sensor.Signal loss message was not displayed.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An alarm issue was reported with the adc device in use with an iphone 11 with ios operating system version 17.2.1 and app version 2.10.2.7677.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced shaking, sweating, feeling bad, laziness and was unable to self-treat, requiring treatment of juice by third-party.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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