FDA Adverse Event Injury Summary report: N

OMNIPOD 5 POD

MDR report key: 20630415 · Received November 7, 2024

Report

Report Number: 3004464228-2024-45400
Event Type: Injury
Date Received: November 7, 2024
Date of Event: October 27, 2024
Report Date: November 7, 2024
Manufacturer: INSULET CORPORATION
Product Code: QFG
UDI-DI: 20385083000432
PMA / PMN Number: K231826
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND MIGRAINES. 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED AT PRINCE CHARLES HOSPITAL IN MERTHYR TYDFIL WITH HYPERGLYCEMIA ON (B)(6) 2024 (REPORTED UNDER MHRA REF 2024/011/005/601/043 INSULET REF (B)(4)). THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 25 AND 36 HOURS ON THE ABDOMEN. WHILST AT THE HOSPITAL THE PATIENT WAS PRESCRIBED MIGRAINE MEDICATION (PRESCRIPTION NAME NOT PROVIDED) THAT REPORTEDLY THE HIGH BLOOD GLUCOSE LEVELS HAD CAUSED. THIS REPORT IS FOR THE PRESCRIBED MIGRAINE MEDICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
71740	OMNIPOD 5 POD	AUTOMATED INSULIN DELIVERY SYSTEM	QFG	INSULET CORPORATION	PT-001443	PH1K01312431	20385083000432

Patients

Seq	Age	Sex	Outcome	Treatment
1	10 YR	Female