BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1190063 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-00815
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    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 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 FOR HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED, AND THE BASAL RATES AND SETTINGS IN THE INSULIN PUMP WERE CORRECT. CUSTOMER'S MOTHER WAS UNABLE TO PERFORM THE HIGH PRESSURE TEST AT THE TIME OF THE CALL. RAN A FIXED PRIME TEST AND PASSED. THE CUSTOMER WAS GOING 5-6 DAYS BETWEEN SET CHANGES. ADVISED THE CUSTOMER OF THE IMPORTANCE TO CHANGE INFUSION SET EVERY 2-3 DAYS. 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 LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization