BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6204011 · Received December 26, 2016

    Report

    Report Number
    2032227-2016-53245
    Event Type
    Malfunction
    Date Received
    December 26, 2016
    Date of Event
    October 30, 2016
    Report Date
    November 30, 2016
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE E21 AFTER BATTERY CHANGE AND MEMORY WAS ERASED DUE TO FAULTY C13 ON IB. PUMP PASSED IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/DELIVERY TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST AND REWIND TEST. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN ERROR ALARM AND RESTARTED. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS NOT PROVIDED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854305 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR