BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1791803 · Received August 4, 2010

    Report

    Report Number
    3004209178-2010-82343
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 590 MG/DL. IT WAS REPORTED THAT THE CUSTOMER HAD AN INFECTION THE NIGHT BEFORE HIS ADMISSION AND IT MAY HAD BEEN CAUSE OF HIS HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE TOTALS FOR BASALS AND BOLUSES WERE CORRECT. RAN A HIGH PRESSURE TEST AND FAILED. 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 38 YR Hospitalization