MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH, PODS 10-PACK; PUMP, INFUSION, INSULIN

Model Number PT-000029

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Pain (1994)

Event Date 04/07/2023

Event Type  malfunction  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.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 the patient's blood glucose level rose above 20 mmol/l (360 mg/dl).The patient reported pain while wearing the pod.When removed from the infusion site, the pod's cannula was found bent.As treatment, a new pod was applied.

• Brand Name: OMNIPOD DASH, PODS 10-PACK
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16725082
• MDR Text Key: 313663865
• Report Number: 3004464228-2023-09454
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000112
• UDI-Public: (01)20385082000112(11)220727(17)240127(10)PD1K07272231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2024
• Device Model Number: PT-000029
• Device Catalogue Number: POD-BLE-C1-529
• Device Lot Number: PD1K07272231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Male