BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1870388 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82921
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE INSULIN PUMP HAD A FROZEN SCREEN, A BATTERY OUT LIMIT ALARM, AND BUTTON UNRESPONSIVENESS. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WERE NOT RESOLVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR