Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 03/06/2024 |
Event Type
Injury
|
Event Description
|
A delivery delay with a replacement adc device was reported.The replacement device was issued due to a "replace sensor" message displaying on the same day of sensor application.Due to delivery delay, customer was unable to test and required unspecified treatment via third-party.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
Sensor (b)(6)has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was seated in mount properly.Data was successfully extracted from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Removed the sensor plug and inspected the plug assembly, no failure mode observed.Current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.Sensor was reprogrammed and simvivo test performed.All results were within specification.Additional testing has been performed for this issue and poise voltage testing was within specification, indicating the sensor was providing accurate glucose readings.All results were within specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
|
|
Manufacturer Narrative
|
Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned applicator and sensor; no issues were observed.The applicator has been fired correctly.The sensor plug is properly seated.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing was performed and all results were within specification.No malfunction or product deficiency was identified.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs 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.This serves as a correction report.Section h11 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A delivery delay with a replacement adc device was reported.The replacement device was issued due to a "replace sensor" message displaying on the same day of sensor application.Due to delivery delay, customer was unable to test and required unspecified treatment via third-party.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|