Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Failure to Fire (2610)
|
Patient Problem
Hyperglycemia (1905)
|
Event Date 06/28/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The exact date of event is unknown.The date entered in section b3 is per the customer's report of "3 weeks ago." 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.
|
|
Event Description
|
A customer reported the needle of the adc applicator was missing and was therefore unable to apply the sensor.The customer experienced symptoms of high glucose and had contact with a healthcare professional who treated them with insulin (dose/type unknown) to decrease glucose levels.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 kits were reviewed and the dhrs showed the 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
|
A customer reported the needle of the adc applicator was missing and was therefore unable to apply the sensor.The customer experienced symptoms of high glucose and had contact with a healthcare professional who treated them with insulin (dose/type unknown) to decrease glucose levels.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|