BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142192 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33020
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES. A CRACKED CASE NEAR THE DISPLAY WINDOW CORNER, CRACKED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT AND A STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ON HER INSULIN PUMP. DURING A BOLUS DELIVERY THE ESC BUTTON STOPPED WORKING. CUSTOMER'S BLOOD GLUCOSE IS 94 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621885 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR