BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4925412 · Received July 20, 2015

    Report

    Report Number
    3004209178-2015-75619
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. UNIT PASSED SELFTEST, UNEXPECTED RESTART ALARM ERROR TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. UNIT PROPERLY CONNECTED TO GLUCOSE SENSOR SIMULATOR. NO LOST SENSOR ALARMS NOTED. UNABLE TO DOWNLOAD TO CARELINK PRO DUE TO MULTIPLE SPANISH SOFTWARE ANOMALY ALARMS IN HISTORY SCREEN. SPANISH SOFTWARE ANOMALY ALARMS ARE DUE TO CORRUPTED HISTORY FILE. UNIT RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL, THAT THE CUSTOMER RECEIVED EXCESSIVE NO DELIVERY ALARMS. IT WAS ALSO REPORTED THAT THE INSULIN PUMP WOULD NOT UPLOAD TO CARELINK. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 247 MG/DL. TROUBLESHOOTING OCCURRED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470224 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 14 YR