Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Hypoglycemia (1912); Muscle Weakness (1967); Diaphoresis (2452); Shaking/Tremors (2515)
|
Event Date 08/16/2022 |
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 device manufacturing 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
|
A customer reported via webform that they received a sensor error message with the adc device.The customer was contacted and further indicated that they experienced symptoms of sweating, trembling, weakness, and required treatment of sugar water provided by spouse.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.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 via webform that they received a sensor error message with the adc device.The customer was contacted and further indicated that they experienced symptoms of sweating, trembling, weakness, and required treatment of sugar water provided by spouse.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.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) was performed and all results were within specification.No malfunction or product deficiency was identified.Therefore issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A customer reported via webform that they received a sensor error message with the adc device.The customer was contacted and further indicated that they experienced symptoms of sweating, trembling, weakness, and required treatment of sugar water provided by spouse.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|