Model Number 71992-01 |
Device Problem
Device Displays Incorrect Message (2591)
|
Patient Problems
Hypoglycemia (1912); Discomfort (2330); Shaking/Tremors (2515)
|
Event Date 09/27/2023 |
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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg 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
|
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 "felt lousy", "trembling", and was unable to self-treat, requiring third-party treatment of "something to eat" by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
|
|
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 "felt lousy", "trembling", and was unable to self-treat, requiring third-party treatment of "something to eat" by a non-healthcare professional.There was no report of death or permanent impairment 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.
|
|
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) and poise voltage testing were performed and all results were within specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.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 "felt lousy", "trembling", and was unable to self-treat, requiring third-party treatment of "something to eat" by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|