BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3812924 · Received May 15, 2014

    Report

    Report Number
    2032227-2014-02364
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST WITH UNITS REMAINING ON THE STATUS SCREEN. UNIT HAD MOTOR ERROR ALARMS DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNIT HAD CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE BECAUSE HER INSULIN PUMP WAS MALFUNCTIONING. CUSTOMER STATED THAT SHE HAD AN MRI WITH THE INSULIN PUMP ATTACHED TO HER. CUSTOMER STATED THAT THE INSULIN PUMP IS ALARMING MOTOR ERROR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290332 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR