BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4811580 · Received June 2, 2015

    Report

    Report Number
    2032227-2015-17676
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    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

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A BUTTON ERROR AND HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE WAS FOUND INSIDE OF THE INSULIN PUMP. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEIR BUTTONS OF THE INSULIN PUMP WERE NOT RESPONDING. THE BLOOD GLUCOSE READING IS 349 MG/DL. THE INSULIN PUMP WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355469 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR