BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 11992223 · Received June 14, 2021

    Report

    Report Number
    3004464228-2021-09280
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    June 6, 2021
    Report Date
    June 9, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NO: FROM NO LOT TO L72189. SERIAL NO : FROM NO SERIAL NUMBER TO 2021026. EXPIRATION DATE :FROM NO DATE TO 8/26/2022. DEVICE MFG DATE: FROM NO DATE TO 2/26/2021. UNIQUE IDENTIFIER (UDI) # FROM (B)(4) TO (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. DUE TO ELEVATED BG LEVELS, PATIENT WAS UNSURE IF CANNULA HAD PROPERLY INSERTED IN THE INFUSION SITE (ABDOMEN). AS TREATMENT, A MANUAL INJECTION WAS DELIVERED, A NEW POD WAS APPLIED AND A CORRECTION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889898 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L72189 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR