Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Bruise/Contusion (1754); Device Embedded In Tissue or Plaque (3165)
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Event Date 12/05/2022 |
Event Type
Injury
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Event Description
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A customer reported the filament of the adc device remained in their skin and caused bruising.The sensor filament was removed and arnidol cream was supplied by a healthcare professional.No further treatment was reported.There was no report of death or permanent injury associated with this event.
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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.There was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre 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 has been performed and no issues were observed.The sensor plug was properly seated.The severed sensor tail was not observed upon visual inspection.Applicator (b)(6) has been returned and investigated.Visually inspection has been performed on the applicator and no issues were observed.It is observed that the applicator was fired correctly.Sensor pack (b)(6) has been returned and investigated.Visually inspection has been performed and damaged transition features was observed.The issue is not confirmed to use due to incorrect assembly method.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported the filament of the adc device remained in their skin and caused bruising.The sensor filament was removed and arnidol cream was supplied by a healthcare professional.No further treatment was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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