BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2863216 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-91168
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE DEVICE HAD MISSING SEGMENTS/PARTIAL DISPLAY AND FROZEN SCREEN DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO CONFIRM A BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY. THE BLOOD GLUCOSE READING WAS 130MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE COUNTED UP TO FIVE, AND THEN IT WAS FROZEN AND BEEPED. INSTRUCTED THE CUSTOMER TO REMOVE THE BATTERY AND TO INSERT A NEW BATTERY, BUT THE FROZEN DISPLAY CONTINUED WITH NO ADVANCEMENT OF THE TIME. THE CALLER ALSO MENTIONED HAVING A BLANK DISPLAY AND THEN A PARTIAL DISPLAY. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR