BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4790966 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58550
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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 HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND A BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR, AFTER THE BUTTONS STOPPED WORKING. CUSTOMER'S BLOOD GLUCOSE WAS 150 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE RECALLED. IT WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. IT WAS FURTHER ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334119 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR