Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 02/25/2023 |
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 device mfg 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
|
Customer experienced excessive bleeding after inserting the adc sensor.Customer was seen at a hospital where the sensor insertion area was cauterized.No further treatment was indicated.There was no report of death or permanent impairment 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 sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.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.
|
|
Event Description
|
Customer experienced excessive bleeding after inserting the adc sensor.Customer was seen at a hospital where the sensor insertion area was cauterized.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|