BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974343 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89082
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    April 16, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED THE REWIND, BASIC OCCLUSION, PRIME AND DISPLACEMENT TEST. THE DEVICE WAS RECEIVED WITH MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR MAYBE HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTE DURING OUR TESTING. UNABLE TO CONFIRM E70 ALARM DUE TO ERASED HISTORY FILE.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 THE THE DEVICE ALARMED DURING THE PRIME PROCESS. TROUBLESHOOTING WAS PERFORMED. THE REPORTER WAS ADVISED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449936 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1