Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2020 |
Event Type
malfunction
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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 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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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) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating early termination).Inspected the plug assembly, no issues were observed.The sensor was reprogrammed but the linearity test could not be performed due to sensor state 6.Dspc-20a issue was added based on sensor state 6.Upon extended investigation, no signs of damage or misuse were observed.Sensor plug was observed to have been seated properly, no cracked neck ,no failure modes observed.Sensor data was extracted and sensor was observed to be in sensor state 6.Sensor was de-cased in cig, corrosion was observed on pcba.Battery was replaced with a known good battery and a linearity test was performed.Linearity test values were interpreted using linearity tool, and passed indicating the electronics of the puck are functioning properly.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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Manufacturer Narrative
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Sensor (b)(6)has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating early termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.A dspc-20a issue was added based on sensor state 6 event log 21.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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