BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522CAS PRDGM INS V2.2 SK EN PR

    MDR report key: 1133350 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-00645
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 432 MG/DL. THE CUSTOMER STATED THAT THE INFUSION SETS WERE CHANGED TWO DIFFERENT TIMES AND HIS BLOOD GLUCOSE CONTINUES TO BE HIGH. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP'S SETTINGS AND PROGRAMMING WERE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND PASSED. THE CUSTOMER STATED THAT THE INSULIN MAY HAVE GOTTEN VERY HOT BECAUSE HE HAD IT IN HIS BAG ALL DAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522CAS PRDGM INS V2.2 SK EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization