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); Cognitive Changes (2551)
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Event Date 07/20/2023 |
Event Type
Injury
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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 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 kits 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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Event Description
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A "scan again in 10 minutes" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness and was "delirious with really bad hypo" and was unable to self-treat, requiring unspecified hcp treatment for a diagnosis of hypoglycemia.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.Visual inspection has been performed on the returned applicator and sensor; no issues were observed.The applicator has been fired correctly.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 and poise voltage 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 "scan again in 10 minutes" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness and was "delirious with really bad hypo" and was unable to self-treat, requiring unspecified hcp treatment for a diagnosis of hypoglycemia.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).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) and poise voltage testing were 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.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the previous report.Correction has been made.
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Event Description
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A "scan again in 10 minutes" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness and was "delirious with really bad hypo" and was unable to self-treat, requiring unspecified hcp treatment for a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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