|
Model Number 19191 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problems
Hyperglycemia (1905); Blood Loss (2597)
|
Event Date 09/19/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including confirming the blue soft cannula is inspected for any damage.
|
|
Event Description
|
It was reported that the patient's blood glucose (bg) levels reached 316 mg/dl, while wearing the pod between 24 and 36 hours on the arm.The pod was removed, the cannula was noted to be bent and the site was bleeding.A new pod was applied to treat the hyperglycemia.
|
|
Search Alerts/Recalls
|
|
|