Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hemorrhage/Bleeding (1888); Hypoglycemia (1912); Vomiting (2144); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 05/21/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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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Event Description
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A replace sensor error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced vomiting, bleeding from the nose, biting the tongue, convulsion, a loss of consciousness and was unable to self-treat, requiring third-party administration of sugar drink.Customer was taken to hospital were a healthcare professional administration of "baxir" (nasal) for treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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A replace sensor error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced vomiting, bleeding from the nose, biting the tongue, convulsion, a loss of consciousness and was unable to self-treat, requiring third-party administration of sugar drink.Customer was taken to hospital were a healthcare professional administration of "baxir" (nasal) for treatment.There was no report of death or permanent impairment associated with this event.
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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 5 (indicating normal termination).Inspected the plug assembly.Cracked sensor neck was observed.The cause of the cracked sensor neck is likely attributed to shipment of the used sensor back to adc for investigation.Sensor state 5 is an indication of normal sensor termination and full wear by the user, therefore the cracked sensor neck observed during investigation occurred post-wear.In addition, the passing of all tests during the investigation indicates that the cracked sensor neck did not impact the sensor's ability to still generate an accurate glucose reading.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.This issue is therefore 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) based on returned product download.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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