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 07/06/2023 |
Event Type
Injury
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Event Description
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Customer reported the filament of the adc device remained in their skin and, as a result, required hcp removal the filament from the customer's arm.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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The reported product is not expected to be returned as reporter indicated the device was discarded.Physical investigation of product is not anticipated.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.The date of event 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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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 and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported the filament of the adc device remained in their skin and, as a result, required hcp removal the filament from the customer's arm.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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