BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170420 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37790
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED PRIME/A33, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. NO AUDIO TONE ALARM NOTED DURING SELF TEST DUE TO BROKEN RED TRANSDUCER WIRE. CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS DOES NOT PROVIDE AN AUDIBLE SOUND WHEN ALARMING. DURING TROUBLESHOOTING, THE CUSTOMER WAS ASKED TO PERFORM A SELF TEST ON THE DEVICE. THE DEVICE FAILED TESTING. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK-UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651855 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR