BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3133991 · Received May 29, 2013

    Report

    Report Number
    2032227-2013-02065
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARM MOTOR ERROR DURING THE BASIC OCCLUSION TEST, DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT WAS RECEIVED WITH ALL CURRENTS WITH IN SPECIFICATIONS. THE INSULIN PUMP PASSED DISPLACEMENT, PRIME, EXCESSIVE NO DELIVERY ALARM TESTS. MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT MOTOR ERROR ALARMS AND UNABLE TO REWIND THE INSULIN PUMP DUE TO THE MOTOR ERROR ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236738 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR