BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-554CAH PRDGM INS PK

    MDR report key: 1882488 · Received October 21, 2010

    Report

    Report Number
    2032227-2010-83023
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    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 REPORTED THAT THE INSULIN PUMP TURNED OFF AND ON REPEATEDLY. IT WAS ALSO STATED THAT THE SCREEN WAS FROZEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-554CAH PRDGM INS PK INFUSION PUMP LZG MEDTRONIC MINIMED MMT-554CAH

    Patients

    Seq Age Sex Outcome Treatment
    1