BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984433 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-89982
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. PUMP RECEIVED WITH SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, BROKEN RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AND THAT INSULIN PUMP IS NOT RECORDING BOLUS INFORMATION. TROUBLESHOOTING WAS PERFORMED TO TEST THE INSULIN PUMPS FUNCTIONALITY. CUSTOMER WAS ASKED TO PROGRAM A 0.2 BOLUS TWICE TO VERIFY IT IN THE HISTORY. BOLUS ONLY RECORDED IN HISTORY ONE. CUSTOMER CURRENT BLOOD GLUCOSE LEVEL IS 139 MG/DL. ADVISED CUSTOMER INSULIN PUMP WILL BE REPLACED AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460849 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR