BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4357278 · Received December 23, 2014

    Report

    Report Number
    2032227-2014-61473
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33,EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. UNIT UNABLE TO COMMUNICATE WITH METER, GLUCOSE SENSOR SIMULATOR AND MINILINK TRASMITTER DUE TO FAULTY Y1 ON RF BOARD. NUMBERS DO NOT RAMP UP ON THEIR OWN OR SCROLL BAR MOVING WITH NO INPUT. UNABLE TO VERIFY SG V BG DUE TO FAILURE ANOMALY. MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP. UNABLE TO VERIFY CHANGE SENSOR ALARM DUE TO FAULTY RF BOARD ANOMALY. 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

    IT WAS REPORTED THAT NUMBERS ON THE INSULIN PUMP WERE RAMPING UP WITHOUT INPUT. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 11.3 MMOL/L. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847711 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1