BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4862390 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19884
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    April 20, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE ESC AND ACT BUTTONS ON THE INSULIN PUMP HAD INTERMITTENT RESPONSE DUE TO CORRODED KEYPAD TRACES. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, AND CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE ACT BUTTON ON THE INSULIN PUMP WAS HARD TO PUSH AND GET IT TO RESPOND. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP 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
    405292 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR