BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-712WWB PRDGM INSULIN BL EN PR

    MDR report key: 1911895 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-83439
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS RESTED AND THE BATTERY WAS CHANGED. ATTEMPTED TO REWIND THE DEVICE, BUT THE ALARM REOCCURRED. RAN A DISPLACEMENT TEST AND THE INSULIN PUMP FAILED THE TESTS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712WWB PRDGM INSULIN BL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712WWB

    Patients

    Seq Age Sex Outcome Treatment
    1