Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Failure to Fire (2610)
|
Patient Problems
Bruise/Contusion (1754); Hypoglycemia (1912); Pain (1994); Diaphoresis (2452)
|
Event Date 07/28/2022 |
Event Type
Injury
|
Event Description
|
A customer reported that they were unable to apply the adc device and as a result, the customer was unable to monitor their blood glucose.The customer experienced symptoms described as ¿soreness, sweating, and bruises on legs nightmarish¿, and was unable to self-treat and was treated with oral glucose by a third party.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kit was reviewed and the dhrs showed the libre 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.
|
|
Manufacturer Narrative
|
Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor, and no issues were observed.The sensor plug was properly seated.Applicator (b)(6) has been returned and investigated.Visually inspection has been performed on the applicator and no issues were observed.It is observed that the applicator was fired correctly.The sharp has been investigated and no issues were observed.Sensor pack (b)(6) has been returned and investigated.Visually inspection has been performed and damage was observed in transition feature.It is observed that the lid was completely peeled off.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A customer reported that they were unable to apply the adc device and as a result, the customer was unable to monitor their blood glucose.The customer experienced symptoms described as ¿soreness, sweating, and bruises on legs nightmarish¿, and was unable to self-treat and was treated with oral glucose by a third party.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|