BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4813447 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61747
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS RECEIVED WITH FAILED BATTERY TEST ALARM AFTER BATTERY CHANGE DUE TO CORRODED BATTERY TUBE. UNIT HAD CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA, CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHED LCD WINDOW. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE LEVELS WERE NOT INCLUDED IN THE REPORT. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. PRODUCT IS BEING RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356747 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1