Model Number 72081-01 |
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 09/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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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A filament issue was reported with the abbott diabetes care (adc) device.The sensor tip was stuck in the arm and had no symptoms.As a result, the customer received a third-party treatment of sensor tip removal by a healthcare professional.No other treatment was reported.There was no report of death or permanent injury associated with this event.
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Event Description
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A filament issue was reported with the abbott diabetes care (adc) device.The sensor tip was stuck in the arm and had no symptoms.As a result, the customer received a third-party treatment of sensor tip removal by a healthcare professional.No other 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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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.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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Search Alerts/Recalls
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