Model Number 71940-01 |
Device Problems
Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
|
Patient Problems
Pain (1994); Device Embedded In Tissue or Plaque (3165)
|
Event Date 03/26/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
It was reported that the adc device's applicator needle became stuck in sensor and customer's arm.Customer experienced pain and was in contact with a healthcare professional who provided unspecified treatment.No further information was provided by reporter.There was no report of death or permanent injury associated with this event.
|
|
Event Description
|
It was reported that the adc device's applicator needle became stuck in sensor and customer's arm.Customer experienced pain and was in contact with a healthcare professional who provided unspecified treatment.No further information was provided by reporter.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|