BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3885193 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85978
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 3, 2014
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC, OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT FUNCTIONED PROPERLY. HOWEVER, LOUD MOTOR NOTED DURING TESTING DUE TO FAULTY MOTOR. MOTOR PASSED MOTOR TEST. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT DUE TO FAULTY MOTOR THE INSULIN PUMP IS MAKING LOUD NOISES WHILE REWINDING. CUSTOMER STATES THAT SHE HAS NOT EXPERIENCED ANY ALARMS. THE CUSTOMER WAS ADVISED TO PERFORM A DISPLACEMENT TEST WITHOUT RESERVOIR, AND IT FAILED. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE LAST BLOOD GLUCOSE READING WAS 102 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360476 530G INSULIN PUMP OZO OZO MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR