BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1853802 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82970
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    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. 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 HAD A BATTERY ALARM AND A FROZEN DISPLAY. TROUBLESHOOTING WAS PERFORMED. WHEN THE BATTERY WAS CHANGED THE DEVICE ALARMED AND THE SCREEN WAS FROZEN. ADVISED THE FATHER TO LET THE INSULIN PUMP RESTS FOR A FEW MINUTES. THEN A NEW BATTERY WAS INSERTED AND THE FROZEN DISPLAY CONTINUED. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR