BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2833211 · Received November 15, 2012

    Report

    Report Number
    2032227-2012-07725
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    April 12, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD UNRESPONSIVE BUTTON DUE TO CORRODED KEYPAD TRACES. UNIT WAS UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO ANOMALY. UNIT HAD LOOSE DRIVE SUPPORT DISK, SCRATCHED DISPLAY WINDOW AND CRACK CASE AT DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED DURING MANUAL PRIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG OYC MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR