BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3051699 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92489
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME/FILL ANOMALY. HOWEVER, THE DEVICE PASSED THE DISPLACEMENT TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WAS MALFUNCTIONING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153831 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWL

    Patients

    Seq Age Sex Outcome Treatment
    1