Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Tachycardia (2095); Dizziness (2194); Shaking/Tremors (2515)
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Event Date 11/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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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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 felt weak, heart racing, hand shaking and dizzy and was unable to self-treat, requiring third-party administration of coke and sweets 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 felt weak, heart racing, hand shaking and dizzy and was unable to self-treat, requiring third-party administration of coke and sweets 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.Visual inspection has been performed on the returned sensor and no physical damage was observed with the sensor patch.Extracted data from returned sensor using approved software.Sensor found to be in state 1 (storage state) and insertion failures were observed in the event log.Watermark was not observed at the base of the tail.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.This complaint is not confirmed due to tail not properly inserted.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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