BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1081826 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-00529
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 STATED SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND VOMITING. THE CUSTOMER STATED HER BLOOD GLUCOSE READING WAS OVER 400 MG/DL SO SHE WENT TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM SHE CHANGED HER INFUSION SET AND HER BLOOD GLUCOSE LEVELS DECREASED. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER WAS ADVISED TO USE A DIFFERENT VIAL OF INSULIN AND TO DISCUSS THE SITUATION WITH HER DOCTOR.

    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 Hospitalization