BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722PNAS PRDGM INS SK EN PW

    MDR report key: 1935117 · Received December 6, 2010

    Report

    Report Number
    2032227-2010-83340
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO A FLATTENED DOME SWITCH ON THE UP ARROW BUTTON. UNABLE TO VERIFY THE BOLUS WIZARD COMPLAINT TO THE KEYPAD ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BOLUS WIZARD FEATURE WAS NOT CALCULATING PROPERLY, CAUSING THE INSULIN PUMP TO DELIVER MORE INSULIN THAN THE CUSTOMER PROGRAMMED. THE CUSTOMER REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722PNAS PRDGM INS SK EN PW INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR