BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982309 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06183
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. NO FROZEN SCREEN NOTED. NO MOISTURE DAMAGE FOUND INSIDE THE PUMP. PUMP RECEIVED WITH SCRATCHED LCD WINDOW. UNIT RECEIVED WITH CRACKED CASE DISPLAY WINDOW CORNER. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS. PUMP RECEIVED WITH BROKEN RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON HER INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP FROZE DUE TO HER BEING OUTSIDE, AND THAT THERE WAS MOISTURE IN THE BACK OF THE DISPLAY SCREEN. CUSTOMER ALSO STATED THAT THERE WERE SEVERAL CRACKS AROUND THE RESERVOIR, BATTERY CASE, AND CORNERS OF THE PUMP. BLOOD GLUCOSE LEVEL WAS 54 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456793 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB A000207446

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR