Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Fatigue (1849); Hot Flashes/Flushes (2153)
|
Event Date 08/14/2022 |
Event Type
Injury
|
Event Description
|
A customer reported a sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced ¿dosing out,¿ tiredness and ¿looked flushed.¿ the customer was unable to self-treat and presented at the hospital.The customer was administered an unspecified medication intravenously for treatment by a health care provider.A reading of 44 mg/dl was obtained on an hcp meter; however, it is unknown if this reading was obtained before or after the reported treatment.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
At this time product has not yet been returned.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 kit were reviewed and the dhrs showed the libre sensor and libre 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.All pertinent information available to abbott diabetes care has been submitted.
|
|
Manufacturer Narrative
|
Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) was performed and all results were within specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A customer reported a sensor error message with the adc device and was unable to obtain readings.As a result, customer experienced ¿dosing out,¿ tiredness and ¿looked flushed.¿ the customer was unable to self-treat and presented at the hospital.The customer was administered an unspecified medication intravenously for treatment by a health care provider.A reading of 44 mg/dl was obtained on an hcp meter; however, it is unknown if this reading was obtained before or after the reported treatment.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|