BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-508UT EA INSULIN TL EN US

    MDR report key: 1210162 · Received October 20, 2008

    Report

    Report Number
    2032227-2008-01798
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 5, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 COMPLAINED OF RECEIVING ALARMS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE LEAD SCREW TEST. THE CUSTOMER STATED THAT HE CLEANED THE LEAD SCREW, BUT THE DRIVER ARMS WERE NOT MOVING FREELY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508UT EA INSULIN TL EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR