BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1882981 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-83187
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DEVICE WAS STUCK IN REWIND MODE, AND THEN SHE WAS ABLE TO EXIT FROM REWIND MODE. RAN A DISPLACEMENT TEST AND THE INSULIN PUMP FAILED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR