BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3990350 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91277
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPOSE DUE TO A FLATTENED DOME SWITCH ON THE UP ARROW BUTTON.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE UP ARROW BUTTON ON THE INSULIN PUMP IS NOT RESPONDING PROPERLY. CUSTOMER STATED THE BUTTON IS NOT CLICKING WHEN BEING PRESSED AND HAS TO PRESS IT MULTIPLE TIMES FOR IT TO WORK. CUSTOMER STATED HE DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUE. BLOOD GLUCOSE LEVEL IS 185 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464484 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR