BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UW EA INSULIN WH EN US

    MDR report key: 1241036 · Received November 21, 2008

    Report

    Report Number
    2032227-2008-01981
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 8, 2007
    Report Date
    November 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMS AND LOSES ALL OF THE SETTINGS EVERY TIME THE BATTERIES ARE CHANGED. DURING TROUBLESHOOTING, THE CUSTOMER STATED THAT SHE HAD BEEN HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER STATED THAT PRIOR TO THE EVENT THE SETTINGS ON THE INSULIN PUMP HAD BEEN ERASED WITHOUT HER REALIZING IT. THE CUSTOMER ALSO STATED THAT THE BUTTONS ON THE INSULIN PUMP DO NOT RESPOND WELL. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization