BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4120121 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29388
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE RECEIVED A NOTICE REGARDING THE BUTTON ON THE INSULIN PUMP THAT IT CAN SCROLL DOWN TO PUT THE INSULIN UNITS. CUSTOMER STATED THAT IT HAS HAPPENED AT LEAST 2 OR 3 TIMES A MONTH WHERE THE SEATBELT WILL PRESS A BUTTON. CUSTOMER STATED HE WOULD CHECK THE DEVICE AND HAVEN'T HAD ANY ISSUES YET. IT WAS OFFERED TO REPLACE THE INSULIN PUMP; CUSTOMER DECLINED. CUSTOMER WANTED TO DISCUSS OPTIONS ABOUT GETTING A NEW DEVICE WITH A NEW WARRANTY. BLOOD GLUCOSE VALUE IS 145 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598098 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS A000114695

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR