Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Cognitive Changes (2551)
|
Event Date 05/01/2023 |
Event Type
Injury
|
Event Description
|
An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness, "loss of knowledge", and was unable to self-treat, requiring third-party treatment of glucagon nasal spray (dose unspecified) by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
The product has been requested back for an investigation.At this time product has not yet 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 device history records (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.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
|
An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness, "loss of knowledge", and was unable to self-treat, requiring third-party treatment of glucagon nasal spray (dose unspecified) by a non-healthcare professional.There was no report of death or permanent impairment 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.Current was applied to the sensor to perform sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing.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.
|
|
Search Alerts/Recalls
|