BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1771942 · Received July 21, 2010

    Report

    Report Number
    3004209178-2010-82094
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 27, 2010
    Report Date
    June 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 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 FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 507MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE MOTHER STATED THAT THE INFUSION SET TUBING MIGHT HAVE BEEN KINKED JUST ABOVE THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS ONE HOUR AHEAD. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND PASSED. 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 LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization