Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Pain (1994); Device Embedded In Tissue or Plaque (3165)
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Event Date 05/10/2023 |
Event Type
Injury
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Event Description
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An hcp reported the filament of the adc device remained in customer's skin and caused pain.Sensor filament was removed by a hcp and no further treatment was reported.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)(4) has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was not returned.Visually inspected the applicator and no issues were observed, applicator had been fired correctly.Visually inspected the sensor pack and damaged transition features were observed.Unable to perform further investigation due to sensor plug not returned, therefore, the issue is not confirmed.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.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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 has been performed on sensor and no issues were observed.The sensor plug was not returned.Visually inspected the applicator and no issues were observed, applicator had been fired correctly.Visually inspected the sensor pack and damaged transition features were observed.Unable to perform further investigation due to sensor plug not returned.Therefore, issue is closed to no product returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) 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 partial product is returned, a physical investigation will be performed, and a follow-up report submitted.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An hcp reported the filament of the adc device remained in customer's skin and caused pain.Sensor filament was removed by a hcp and no further treatment was reported.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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