BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972316 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88824
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A BUTTON ERROR DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. NO MOISTURE DAMAGE ON ELECTRONICS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY SCREEN, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND MISSING END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. SHE STATED THAT SHE WORE THE INSULIN PUMP IN THE BRA AREA AND WAS ADVISED TO WEAR IT IN A POUCH OR BABY SOCK TO AVOID MOISTURE DAMAGE. THE BLOOD GLUCOSE READING WAS 102 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448151 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 44 YR