Model Number 71953-01 |
Device Problem
Battery Problem (2885)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/07/2023 |
Event Type
Injury
|
Event Description
|
A customer reported a fast-draining battery issue with the adc device.It was indicated that the customer received unspecified treatment.No additional information was provided.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg 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.
|
|
Event Description
|
A customer reported a fast-draining battery issue with the adc device.It was indicated that the customer received unspecified treatment.No additional information was provided.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Search Alerts/Recalls
|