Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 04/02/2024 |
Event Type
Injury
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Event Description
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A "check sensor" error message was reported with the abbott diabetes care (adc) device and the customer was unable to obtain readings.As a result, the customer had a seizure and lost consciousness.The customer was unable to self-treat so an ambulance was called and the customer was given glucose injection (dose unknown) by a healthcare professional (hcp) due to a blood glucose reading of "1.2".There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 1 (storage state).Insertion failures were observed.The watermark was observed at the base of the tail indicating the sensor being properly inserted.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a known good reader.Therefore, the issue is not confirmed.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.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.Section d4 (serial number) was updated from (b)(6) to (b)(6).All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A "check sensor" error message was reported with the abbott diabetes care (adc) device and the customer was unable to obtain readings.As a result, the customer had a seizure and lost consciousness.The customer was unable to self-treat so an ambulance was called and the customer was given glucose injection (dose unknown) by a healthcare professional (hcp) due to a blood glucose reading of "1.2".There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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