BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1002135 · Received February 25, 2008

    Report

    Report Number
    3004209178-2008-00139
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO BATTERY TUBE CONNECTOR NOT PLUGGED IN PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A BLANK SCREEN. THE CUSTOMER STATED HER BLOOD GLUCOSE READING WAS 584 MG/DL AND SHE HAD TO TAKE A 10 UNIT MANUAL INJECTION TO TREAT. TROUBLESHOOTING WAS PERFORMED AND THE SCREEN REMAINED BLANK. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1