BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 9903768 · Received March 31, 2020

    Report

    Report Number
    3004464228-2020-04684
    Event Type
    Malfunction
    Date Received
    March 31, 2020
    Date of Event
    March 19, 2020
    Report Date
    March 24, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. 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. 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 THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 17.6 MMOL/L (316.8 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT REPORTED THE CANNULA DID NOT PROPERLY INSERT IN THE INFUSION SITE (ABDOMEN). AS TREATMENT, A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367513 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C11041951 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR