BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 23498681 · Received November 7, 2025

    Report

    Report Number
    3004464228-2025-54845
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 23, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000432
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT INFORMATION UPDATE WAS PROVIDED WITH A DIFFERENT SERIAL NUMBER THAN WAS REPORTED AND NOTED ON THE INITIAL MDR. CORRECTION TO D(4): LOT NUMBER CHANGED FROM 190457 TO 0190457.

    Additional Manufacturer Narrative · 0

    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. 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. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.5-P001 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: L2+ *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.

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. INSPECTION OF THE NEEDLE MECHANISM AND CANNULA ASSEMBLY FOUND NO ISSUES THAT WOULD RESULT IN THE CANNULA INSERTING IMPROPERLY. THE CAUSE OF THE REPORTED IMPROPER INSERTION COULD NOT BE CONCLUSIVELY DETERMINED. NO DAMAGES WERE FOUND WITH THE CANNULA ASSEMBLY THAT WOULD RESULT IN LEAKING DURING WEAR. A LEAK TEST WAS PERFORMED, AND NO LEAKAGES WERE OBSERVED ALONG THE ENTIRE FLUID PATH. THE ADHESIVE PAD AND WELDS WERE INSPECTED, AND NO ABNORMALITIES WERE FOUND. ALTHOUGH THE INVESTIGATION FOUND NO EVIDENCE OF ANY DAMAGE, THE CAUSE OF THE REPORTED ADHESIVE ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THEIR BLOOD GLUCOSE (BG) LEVEL REACHED 18 MMOL/L (324 MG/DL), WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS ON THE ARM. THE PATIENT REPORTED THE CANNULA DEPLOYED DURING ACTIVATION, BUT DID NOT INSERT INTO THEIR SKIN. THIS CAUSED THE POD TO LEAK INSULIN AND THE ADHESIVE TO BECOME LOOSE. AS TREATMENT, A NEW POD WAS SUCCESSFULLY APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174170 OMNIPOD 5 POD AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001443 PH1M02262511 20385083000432

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female