BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722WWS PRDGM INSULIN SK EN ML

    MDR report key: 1033048 · Received April 22, 2008

    Report

    Report Number
    3004209178-2008-00266
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 UNK WHETHER 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 INFO 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 NO DELIVERY ALARM NO LONGER WORKS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT PASS THE HIGH PRESSURE TEST. THE INSULIN PUMP DID PASS THE SELF TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722WWS PRDGM INSULIN SK EN ML INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1