Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 01/18/2022 |
Event Type
Injury
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Event Description
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A customer reported an error with the freestyle libre 2 sensor upon activation on the afternoon of (b)(6) 2022, and was unable to obtain sensor readings.As a result, the customer was unaware when he became hypoglycemic, and subsequently experienced a loss of consciousness with fall which injured leg.The customer's partner treatment customer with glucose injection, and the customer went to clinic to check leg.There was no further information provided.There was no report of death or permanent injury 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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) 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.
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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.Therefore issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported an error with the freestyle libre 2 sensor upon activation on the afternoon of 18 jan 2022, and was unable to obtain sensor readings.As a result, the customer was unaware when he became hypoglycemic, and subsequently experienced a loss of consciousness with fall which injured leg.The customer's partner treatment customer with glucose injection, and the customer went to clinic to check leg.There was no further information provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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