BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-712EWS PRDGM INSULIN SK ZH

    MDR report key: 1172682 · Received September 19, 2008

    Report

    Report Number
    3004209178-2008-00754
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K053177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 WAS PRIMING ABNORMALLY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT AND SELF TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712EWS PRDGM INSULIN SK ZH INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712EWS

    Patients

    Seq Age Sex Outcome Treatment
    1