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

Model Number PT-000029

Device Problem Difficult to Insert (1316)

Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that the patient's glucose reached 28 mmol/l (504 mg/dl) while wearing the pod.Upon removal, it was noticed that the cannula was not properly inserted into the skin and the site was bruised.

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.It was reported the cannula was possibly not inserted correctly into the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.No lot release records were reviewed, as the product lot number was not provided.

• 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: 16809845
• MDR Text Key: 313952710
• Report Number: 3004464228-2023-10540
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000112
• UDI-Public: (01)20385082000112(17)000101(10)
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PT-000029
• Device Catalogue Number: POD-BLE-C1-529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Male