BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4954339 · Received July 30, 2015

    Report

    Report Number
    3004209178-2015-79023
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE ON THE LCD BOARD, MOTHERBOARD, INTERFACE BOARD, RADIO FREQUENCE BOARD, MOTOR, VIBRATOR AND BATTERY TUBE ASSEMBLY DURING VISUAL INSPECTION. RECEIVED WITH PUMP CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE MOTHER REPORTED THE INSULIN PUMP WAS SUBMERGED IN CHLORINATED WATER. CUSTOMER'S BLOOD GLUCOSE WAS 271 MG/DL. THE MOTHER REPORTED FLUID WAS PRESENT UNDER THE LCD DISPLAY. THE MOTHER ALSO REPORTED THE INSULIN PUMP PASSED A SELF-TEST DURING TROUBLESHOOT. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498479 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR