Model Number 71992-01 |
Device Problems
Device Alarm System (1012); No Audible Alarm (1019)
|
Patient Problems
Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)
|
Event Date 02/04/2023 |
Event Type
Injury
|
Event Description
|
An alarm issue was reported with the abbott diabetes care (adc) application in use with an android operating system.The low and high glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced sweating, tremor and palpitations and was unable to self-treat, requiring treatment by glucagon injection (dose unknown) provided by non-healthcare professional (non-hcp).There was no report of death or permanent injury 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.There was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensors 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.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.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarm was successfully activated.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
An alarm issue was reported with the abbott diabetes care (adc) application in use with an android operating system.The low and high glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced sweating, tremor and palpitations and was unable to self-treat, requiring treatment by glucagon injection (dose unknown) provided by non-healthcare professional (non-hcp).There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|