BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 10032622 · Received May 7, 2020

    Report

    Report Number
    3004464228-2020-06472
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 5, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450, PT-000002-GBR-ENG-MM-AW REV. 002 11/19/ BLOOD GLUCOSE READINGS 4 / PAGE 55: WARNINGS: BLOOD GLUCOSE READINGS BELOW 3.9 MMOL/L MAY INDICATE HYPOGLYCAEMIA LOW BLOOD GLUCOSE). BLOOD GLUCOSE READINGS ABOVE 13.9 MMOL/L MAY INDICATE HYPERGLYCAEMIA HIGH BLOOD GLUCOSE). FOLLOW YOUR HEALTHCARE PROVIDER¿S SUGGESTIONS FOR TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE (BG) READ "HIGH" (>27.8 MMOL/L) (>500MG/DL) WHILE WEARING THE POD FOR LONGER THAN 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND A CORRECTION BOLUS WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498725 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C11041951 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR