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 12/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been requested back for investigation.A follow-up report will be submitted once additional information is obtained.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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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.No product has been returned.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) was returned and investigated.Visual inspection was performed on the returned sensor, no issues were observed.Data was extracted using approved software, and extraction was successful.Extended investigation was performed upon the returned sensor and did not observe any evidence of misuses or abnormalities.The patch data was extracted.The returned patch was de-cased and no issues were observed on the patch component or sensor flag.Glucose solution test was performed to check the accuracy test of the returned patch's reading.No significant inaccuracies were observed.No other issues were identified.No evidence of a product malfunction was observed during the investigation therefore this 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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