BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722LCAB PRDGM INS BL EN LN

    MDR report key: 1935114 · Received December 6, 2010

    Report

    Report Number
    2032227-2010-83336
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 REPORTED THAT THE INSULIN PUMP SCREEN WOULD TURN OFF AND ON DURING NORMAL USE. IT WAS ALSO STATED THAT THE INSULIN PUMP HAD A FROZEN SCREEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LCAB PRDGM INS BL EN LN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LCAB

    Patients

    Seq Age Sex Outcome Treatment
    1