BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241458 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-48601
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME DURING PRIME ALARM TESTS AND MOTOR ERROR ALARMED DURING BASIC OCCLUSION TEST DUE TO MOISTURE DAMAGE NOTED IN FORCE SENSOR RESISTER. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP WAS NOT ADMINISTERING ANY INSULIN. CUSTOMER'S BLOOD GLUCOSE WAS 179 MG/DL. CUSTOMER SYMPTOMS FOR HIGH BLOOD GLUCOSE WERE HEADACHES. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTED THE PISTON ON THE DEVICE WAS NOT MOVING. THE DEVICE HAD A MOTOR ANOMALY. CUSTOMER DECLINED FURTHER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722797 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR