BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-712WWB PRDGM INSULIN BL EN PR

    MDR report key: 1853419 · Received September 27, 2010

    Report

    Report Number
    3004209178-2010-82894
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    September 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED SEVERAL TIMES DURING PRIME. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND THE DEVICE FAILED THE TEST. NO FURTHER INFORMATION 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