BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-507UG EA INSULIN GY EN US

    MDR report key: 1203800 · Received October 10, 2008

    Report

    Report Number
    2032227-2008-01766
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K960001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 LOW BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING WAS 58 MG/DL. THE CUSTOMER WAS NOT HOSPITALIZED AS A RESULT OF LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE LEAD SCREW TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-507UG EA INSULIN GY EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-507UG

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR