Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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The customer's product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing 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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Event Description
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Customer reported that part of the filament of the adc device remained in their arm, customer had contact with an hcp and had the filament removed and the sensor site was disinfected.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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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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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Customer reported that part of the filament of the adc device remained in their arm, customer had contact with an hcp and had the filament removed and the sensor site was disinfected.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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