BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3251091 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96152
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. THE DISPLAY FUNCTIONS PROPERLY AND NO RAINBOW EFFECT ON THE DISPLAY WAS NOTED. THE DEVICE HAD MISSING SEGMENTS ON DISPLAY OR OVERHEATS DISPLAY NOTED. THE UNIT HAD SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DISPLAY DID NOT RETURN TO NORMAL AFTER CHANGING THE BATTERY. THE CALLER ALSO STATED THAT THE INSULIN PUMP WAS DELIVERING MORE INSULIN. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 180MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352290 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR