BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972057 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05082
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 24, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED IN 50C OVEN FOR TWO DAYS AND NO BLANK DISPLAY NOTED. NO DAMAGE FOUND ON THE C13/LCD ISOLATION TAPE NOTED. NO UNEXPECTED OFF, NO POWER ALARM NOTED. NO A21ALARM NOTED. NO RESET ANOMALY DURING TESTING NOTED. THE DEVICE HAD HIGH IDLE CURRENT DUE TO MOISTURE DAMAGE ON ELECTRONICS. THE DEVICE WAS RECEIVED WITH CRACKED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP HAD A BLANK DISPLAY FOR THE FIFTH TIME. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 176 MG/DL. CUSTOMER WAS EXPLAINED WHAT MAY CAUSE THE DISPLAY TO BE BLANK. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER HAS RECEIVED A NEW BATTERY CAP. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448469 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR