BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974341 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89080
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM OCCURED DURING THE OCCLUSION TEST. THE DEVICE WAS UNABLE TO PRIME DUE TO FAULTY FSR. THE MOTOR PASSED MOTOR TEST. THE DEVICE WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS, RESERVOIR TUBE LIP AND SCRATCHED DISPLAY 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

    IT WAS REPORTED THAT THE INSULIN PUMP HAD ALARMED DURING THE BOLUS PROCESS. THE ALARM REPEATED ITSELF TWICE AFTER THE INITIAL OCCURRENCE. THE BLOOD GLUCOSE READING AT THE TIME WAS 367 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451311 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