BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5171699 · Received October 23, 2015

    Report

    Report Number
    2032227-2015-58744
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH BUTTON ERROR ALARM AND HAD INTERMITTENT ACT AND DOWN BUTTONS RESPONSE DUE TO CORRODED KEYPAD TRACES. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND THE KEYPAD BUTTONS ARE NOT RESPONSIVE. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 135 MG/DL UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND TO RETURN THE PRODUCT FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700960 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR