Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Hypoglycemia (1912); Blurred Vision (2137); Shaking/Tremors (2515)
|
Event Date 11/01/2023 |
Event Type
Injury
|
Event Description
|
A customer reported a "scan again in 60 minutes" message from the adc device.The customer was unable to obtain readings and experienced tremors, asthenia and blurred vision requiring treatment of fruit juice provided by the non-health professional.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
The reported product is not expected to be returned as reporter indicated the device was discarded.Physical investigation of product is not anticipated.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.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 a "scan again in 60 minutes" message from the adc device.The customer was unable to obtain readings and experienced tremors, asthenia and blurred vision requiring treatment of fruit juice provided by the non-health professional.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.An extended investigation has been performed for the reported complaint and it has been determined that 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.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
|
|
Search Alerts/Recalls
|