Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165)
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Event Date 02/07/2023 |
Event Type
Injury
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Event Description
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A caller reported that the sensor tip of the adc device remained in the skin of the customer.The customer experienced bleeding and had contact with a healthcare professional who provided unknown treatment.No other details were provided.There was no report of death or permanent injury associated with this event.
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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 device manufacture date 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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that the freestyle 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 libre sensor, 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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Event Description
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A caller reported that the sensor tip of the adc device remained in the skin of the customer.The customer experienced bleeding and had contact with a healthcare professional who provided unknown treatment.No other details were provided.There was no report of death or permanent injury associated with this event.
|
|
Event Description
|
A caller reported that the sensor tip of the adc device remained in the skin of the customer.The customer experienced bleeding and had contact with a healthcare professional who provided unknown treatment.No other details were provided.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential 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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