BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UC EA INSULIN CH EN US

    MDR report key: 1013587 · Received March 13, 2008

    Report

    Report Number
    2032227-2008-00484
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 1, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER STATED THAT THE INSULIN PUMP HAD THE NUMBER 11.0 FLASHING ON THE SCREEN. TROUBLESHOOTING WAS ATTEMPTED, BUT THE BUTTONS WERE NOT RESPONDING ON THE INSULIN PUMP, EVEN AFTER THE BATTERY WAS REPLACED. THE CUSTOMER'S DAUGHTER STATED, SHE WOULD TAKE THE CUSTOMER TO THE EMERGENCY ROOM FOR TREATMENT. THE CUSTOMER LATER CALLED STATING SHE WAS HOSPITALIZED AND HER BLOOD GLUCOSE LEVELS WERE TOO HIGH FOR THE GLUCOSE METER TO READ. THE CUSTOMER ALSO HAD KETONES UPON ADMISSION. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization