Model Number 72079-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 03/07/2024 |
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.The customer¿s product has been requested for investigation.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre reader and no trends were identified that would indicate any product related issues.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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.Customer experienced a signal loss alarm and was unable to receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced sweating, shaking, no strength, and could not stand up and was unable to self-treat, requiring treatment of cola and "grape sugar" for treatment by a non-healthcare provider.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated.Visual inspection was performed on the returned reader; no issues were observed.Reader was tested for volume and vibration settings through different testing and all results were within the specifications.The isf (interstitial fluid) data was downloaded using approved software and tested.An analysis of ble (bluetooth low energy) rssi (received signal strength indicator) was performed, and signal loss alarms were caused by low or not present ble rssi signal.Therefore, this issue is not confirmed.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.Section d1 (brand name) and d4 (model #) were updated based on returned product download.Section d4 (serial number) was updated from (b)(6).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.Customer experienced a signal loss alarm and was unable to receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced sweating, shaking, no strength, and could not stand up and was unable to self-treat, requiring treatment of cola and "grape sugar" for treatment by a non-healthcare provider.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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