Model Number 72081-01 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs 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.N/a was selected for section pma/510k as customer is using fs libre 3 sensor with fs libre reader.Fs libre 3 sensor with reader is not approved for market in us, however libre 3 is same/similar to libre 2 which is currently on market in the us.
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Event Description
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A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) was returned and visually inspected and no issues were observed.Flex sensor was returned.Data extraction was successful.Low sensor signal was observed.Observed watermark at the base of the tail.Sensor was de-cased and performed visual inspection and no issues were observed.Therefore, the issue is not confirmed due to early sensor removal.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
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Search Alerts/Recalls
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