BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974300 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05227
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACE. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP. NO MOISTURE DAMAGE NOTED ON ELECTRONIC ASSEMBLY OR ON MOTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE IS A POROBLEM WITH THE BUTTONS ON THE INSULIN PUMP NOT WORKING AS EXPECTED. THEY PRESS THE END BUTTON AND IT MAKES A SOUND. THE BLOOD GLUCOSE AT THAT TIME WAS 147MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450013 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR