BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1812260 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82563
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 11, 2008
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS TWO YEARS AGO. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE INSULIN WAS STORED IN THE REFRIGERATOR AND A COLD INSULIN WAS USED. REVIEWED PROGRAMMING, BASAL, TIME/DATE, DAILY TOTALS, AND BOLUS HISTORY AND ALL APPEARED TO BE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization