BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-712NAS PRDGM INSULIN SK EN

    MDR report key: 1931462 · Received December 8, 2010

    Report

    Report Number
    2032227-2010-83383
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    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 REPORTED THAT THE NUMBERS ON THE SCREEN WERE RAMPING UP ON THEIR OWN AFTER ATTEMPTING TO PROGRAM A BOLUS. AFTER SOME TROUBLESHOOTING WAS DONE, THE INSULIN PUMP ALARMED WITH BATTERY OUT LIMIT, THEN THE SCREEN FROZE. THE ALARM COULD NOT BE CLEARED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR