BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512NAP PRDGM INSULIN PL EN

    MDR report key: 1210234 · Received October 22, 2008

    Report

    Report Number
    2032227-2008-01815
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S GRANDMOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE OVER 500 MG/DL. THE CUSTOMER'S GRANDMOTHER STATED THAT PRIOR TO THE EVENT THE INSULIN PUMP HAD ALARMED BUTTON ERROR AND THE BUTTONS WERE NOT RESPONDING. TROUBLESHOOTING WAS PERFORMED, AND AFTER REPLACING THE BATTERY, THE BUTTONS RESPONDED NORMALLY. HOWEVER, AT THE TIME OF THE EVENT THE BUTTONS WERE UNRESPONSIVE AGAIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512NAP PRDGM INSULIN PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization