BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3971998 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88606
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY, OFF NO POWER, OR BATTERY OUT LIMIT ALARMS NOTED. UNIT PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. NO MOTOR ERROR ALARM NOTED. MOTOR PASSED MOTOR TEST. UNABLE TO PRIME DURING PRIME/A33 TEST DUE TO FAULTY FSR (GOLD). NO UNEXPECTED AUTO OFF ALARM NOTED DURING TESTING. UNIT RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLANK DISPLAY ON THE INSULIN PUMP. CUSTOMER ALSO STATED THAT THEY RECEIVED SEVERAL ERROR ALARMS INCLUDING A MOTOR ERROR ALARM DURING BASAL. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 331 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447080 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 67 YR