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 12/23/2022 |
Event Type
malfunction
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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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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.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor, no issues were observed.Watermark was not observed at the base of the tail.Data was successfully extracted from the returned sensor using approve software.The sensor was found to be in sensor state 8, observed sensor signal low error message along with a drop in glucose values. de-cased and performed visual inspection, no issue were observed.Historical log showed a normal glucose pattern over the course of the sensors life.Low glucose values were observed towards the end of the sensors use is an indication of physical complications with the customer as their body degraded the accuracy of the sensor tail.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 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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