BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1851612 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-82922
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT HE WAS TAKEN TO THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE AND RELEASED. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 40 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE HAD DONE YARD WORK FOR ABOUT TWO HOURS PRIOR TO INCIDENT. THE CUSTOMER STATED THAT HE WAS NOT ALERT WHEN HIS WIFE AND DAUGHTER FOUND HIM AND PARAMEDICS WERE CALLED. REVIEWED PRIMING TECHNIQUES AND INSULIN CONCENTRATION AND THEY WERE CORRECT. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE STATUS SCREEN UNITS MATCHED TO THE AMOUNT OF INSULIN LEFT IN THE RESERVOIR. RAN 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-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization