FDA Adverse Event Malfunction Summary report: N

OMNIPOD 5 PODS

MDR report key: 22488370 · Received July 12, 2025

Report

Report Number: 3004464228-2025-30809
Event Type: Malfunction
Date Received: July 12, 2025
Date of Event: June 10, 2025
Report Date: July 12, 2025
Manufacturer: INSULET CORPORATION
Product Code: QFG
UDI-DI: 20385083000579
PMA / PMN Number: K231826
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_ANDROID. OMNIPOD SOFTWARE APP VERSION: 3.1.1. OPERATING SYSTEM: TP1A.220624. 014.G981USQSCHYC1. HARDWARE: SM-G981U. CGM SENSOR TYPE: G7. *PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

Description of Event or Problem · 0

IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 400 MG/DL WHILE WEARING THE POD FOR LONGER THAN 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. INFORMATION ON TREATMENT WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
838994	OMNIPOD 5 PODS	OMNIPOD 5 PODS	QFG	INSULET CORPORATION	PT-001662	PH1U08232411	20385083000579

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 YR	Female