BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1252839 · Received December 4, 2008

    Report

    Report Number
    2032227-2008-02026
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE OVER 400 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME AND HIGH PRESSURE TESTS PASSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization