BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4760635 · Received May 8, 2015

    Report

    Report Number
    3004209178-2015-54413
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPOND DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED DURING TESTING. VISUAL INSPECTION WAS PERFORMED AND NO TRACES OF MOISTURE WERE NOTED ON THE ELECTRONIC OR MOTOR ASSEMBLIES. THE DEVICE HAD CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, AND MINOR SCRATCHES ON THE 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'S MOTHER REPORTED VIA PHONE CALL, THE CUSTOMER'S INSULIN PUMP HAD ALARMED BUTTON ERROR. CUSTOMER'S MOTHER PASSED THE PHONE TO THE CUSTOMER AND THE CUSTOMER PERFORMED TROUBLESHOOTING. CUSTOMER'S BLOOD GLUCOSE WAS 8.1 MMOL/L. CUSTOMER STATED SHE WAS ACTIVE AND SWEATING, WHEN ASKED IF THE DEVICE WAS EXPOSED TO MOISTURE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE INSULIN PUMP NEEDED TO BE REPLACED. CUSTOMER AGREED TO RETURN THE INSULIN PUMP FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304720 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAH

    Patients

    Seq Age Sex Outcome Treatment
    1