BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141769 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33539
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. CUSTOMER STATED THAT THE MOTOR MALFUNCTIONED YESTERDAY AND THE PUMP IS NO LONGER WORKING. CUSTOMER STATED THAT HE DOES NOT HAVE THE PUMP WITH HIM RIGHT NOW. CUSTOMER STATED THAT THE ALARM OCCURRED DURING PRIMING. CUSTOMER WILL CALL BACK TO VERIFY THE PUMP SERIAL NUMBER. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621056 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR