BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1921805 · Received December 6, 2010

    Report

    Report Number
    3004209178-2010-83519
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 REPORTED HAVING A CAR ACCIDENT DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER WAS HOSPITALIZED FOR A MEDICAL TREATMENT. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 98 MG/DL. THE CUSTOMER STATED THAT SHE TESTED HER GLUCOSE LEVEL WHILE DRIVING AND IT WAS 46 MG/DL. THE CUSTOMER ATE CHOCOLATE BAR, AND ATTEMPTED TO FIND A PLACE TO EAT TO TREAT HER LOW BLOOD GLUCOSE. THE CUSTOMER CANNOT RECALL WHAT HAPPENED AFTER SHE LOST CONSCIOUSNESS AND CRASHED. THE CUSTOMER STATED THAT SHE RECALLED THE PARAMEDICS WERE ON THE SCENE AND TREATED HER WITH INSULIN DRIP, AND THEN SHE WAS TAKEN TO THE HOSPITAL FOR TESTS TO MAKE SURE THE BABY IS OK AS THE CUSTOMER IS PREGNANT. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN IN THE RESERVOIR MATCHED TO THE STATUS SCREEN. PERFORMED A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization