BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241456 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-48600
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    July 18, 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
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE ON THE LCD DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON LCD DISPLAY WINDOW, CRACKS ON THE BATTERY TUBE THREADS, CRACKS ON THE RESERVOIR TUBE LIP, CRACKS ON THE RESERVOIR TUBE WINDOW, CRACKS ON THE RESERVOIR TUBE, AND CRACK ON THE BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSULIN PUMP HAD A CRACK ON THE RIGHT CORNER OF THE SCREEN. CUSTOMER WAS UNSURE HOW THE DAMAGE OCCURRED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE WAS 142 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721874 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR