Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 12/02/2022 |
Event Type
Injury
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Event Description
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A customer reported a ¿replace sensor¿ error message with the adc device and was unable to obtain readings.As a result, customer experienced hypoglycemia, tremor, sweating and was unable to self-treat.Customer required third-party intervention by partner who administered glucagon as treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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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.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 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported a ¿replace sensor¿ error message with the adc device and was unable to obtain readings.As a result, customer experienced hypoglycemia, tremor, sweating and was unable to self-treat.Customer required third-party intervention by partner who administered glucagon as treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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