BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5203099 · Received November 4, 2015

    Report

    Report Number
    2032227-2015-63104
    Event Type
    Malfunction
    Date Received
    November 4, 2015
    Date of Event
    October 18, 2015
    Report Date
    October 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE AND ALARMED FOR A BUTTON ERROR DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE WAS NOTED TO THE LIQUID CRYSTAL DISPLAY CIRCUIT BOARD, MOTHER BOARD, INTERFACE BOARD, RADIO FREQUENCY BOARD, MOTOR, VIBRATOR OR BATTERY TUBE ASSEMBLY DURING THE VISUAL INSPECTION. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP MADE A LOUD BEEPING SOUND AND THEN NOTICED THAT THERE WAS MOISTURE ON THE PUMP. TROUBLESHOOTING WAS INITIATED FOR THE PUMP EXPOSURE TO FLUID. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. THE CUSTOMER WAS WEARING HER INSULIN PUMP IN HER BRA WHILE AT CHURCH; SHE BELIEVES THAT SHE SWEATED ON IT. THE CONSTANT TONE WAS UNABLE TO BE CLEARED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733546 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR