FDA Adverse Event Malfunction Summary report: N

OMNIPOD 5 PODS

MDR report key: 20048078 · Received August 22, 2024

Report

Report Number
MW5158760
Event Type
Malfunction
Date Received
August 22, 2024
Report Date
August 20, 2024
Manufacturer
INSULET CORPORATION
Product Code
QFG
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PHARMACIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

OMNIPOD (INSULET) HAS CAME OUT WITH NEW OMNIPOD 5 COMPATIBLE WITH DEXCOM G6 AND G7 WHICH HAS SAME EXACT NDC THAT OF OMNIPOD 5 COMPATIBLE ONLY WITH DEXCOM G6. ACCORDING TO SALES REPRESENTATIVE OF INSULET BOTH PODS ARE DIFFERENT IN TECHNOLOGY LIKE CHIP OR SOMETHING AND SO OLD PODS ARE NOT GOING TO WORK WITH DEXCOM G7. AS THEY BOTH HAVE EXACT SAME NDC THERE IS NO WAY TO DIFFERENTIATE THEM AND IT WILL CAUSE SO MANY MEDICATION ERRORS AS THE OLD PODS ARE GOING TO BE IN MARKET FOR AT LEAST FEW MONTHS IF NOT YEARS UNTIL THEY ARE EXPIRED. WORKING IN THE PHARMACY SPECIALIZED WITH DIABETES, VERY CONCERN ABOUT THIS ISSUE AND POTENTIAL SAFETY ISSUES PATIENT WILL RUN INTO IF THEY ARE EXPECTING NEW PODS BUT GETS OLD PODS AS NDC BEING SAME ONE CANNOT DIFFERENTIATE IT. FEW LINKS TO HELP RESEARCH MORE ABOUT IT: HTTPS://WWW.OMNIPOD.COM/CURRENT-PODDERS/RESOURCES/OMNIPOD-5/FAQS/DEXCOM-G7, HTTPS://WWW.OMNIPOD.COM/CURRENTPODDERS/ RESOURCES/OMNIPOD-5/FAQS/TROUBLESHOOTING/PODS-COMPATIBLE-DEXCOM-G6-G7, HTTPS://WWW.OMNIPOD.COM/INNOVATION/NEW-COMPATIBLE-DEVICES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
231898 OMNIPOD 5 PODS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown