BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4131841 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31432
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    INSULIN PUMP RECEIVED WITH NO ACT AND DOWN BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP WAS UNABLE TO VERIFY FOR FAILED BATTERY TEST AND BATTERY OUT OF LIMIT ALARM DUE TO NO ACT AND DOWN BUTTON RESPONSE. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED PUMP BELT CLIP SLOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BUTTONS ON THE INSULIN PUMP WERE NOT RESPONDING. CUSTOMER REMOVED AND REPLACED THE BATTERY AND RECEIVED A BATTERY OUT LIMIT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD RECENTLY BEEN EXPOSED TO SWEAT. BLOOD GLUCOSE LEVEL WAS 130 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612494 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR