BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2884448 · Received December 22, 2012

    Report

    Report Number
    3004209178-2012-91528
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Date of Event
    October 10, 2012
    Report Date
    December 6, 2012
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY AS A RESULT OF MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE FROZEN SCREEN. MOISTURE DAMAGE ALSO WAS FOUND ON THE MOTOR. THE DEVICE WAS RECEIVED WITH MISSING END CAP STICKER. 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 CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND. IT WAS STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWB

    Patients

    Seq Age Sex Outcome Treatment
    1