BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522WWP PRDGM INSULIN PL EN ML

    MDR report key: 1060742 · Received June 11, 2008

    Report

    Report Number
    3004209178-2008-00410
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS EVER SINCE STARTING ON THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET, BUT CONTINUED TO HAVE HIGH BLOOD GLUCOSE LEVELS. IT WAS STATED THAT WHEN SHE USED HER OLD INSULIN PUMP HER BLOOD GLUCOSE LEVELS ARE FINE. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT PASS THE HIGH PRESSURE TEST. THE CUSTOMER WAS NO LONGER COMFORTABLE USING THE INSULIN PUMP. THE INSULIN PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522WWP PRDGM INSULIN PL EN ML INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MMT-522WWP

    Patients

    Seq Age Sex Outcome Treatment
    1