Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Hypoglycemia (1912); Vomiting (2144); Discomfort (2330); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
|
Event Date 04/01/2023 |
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 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 repeated start cycle error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced shaking, discomfort, disoriented and vomiting and was unable to self-treat, requiring third-party administration of food for treatment.No further treatment information was provided.There was no report of death or permanent impairment associated with this event.
|
|
Event Description
|
A repeated start cycle error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced shaking, discomfort, disoriented and vomiting and was unable to self-treat, requiring third-party administration of food for treatment.No further treatment information was provided.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Reader did not turn on with the button, strip, or usb cable insertion.The reader was connected to the pc and the reader was not recognized.The reader turned on when pressure was applied to the cpu.Scanned known good sensor with the returned reader.No error messages were observed.Therefore, this issue is not confirmed.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs(device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.Dhrs(device history review) for the fs libre reader was reviewed and the dhrs showed the fs libre reader passed all tests prior to release.If partial 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
|