BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4132492 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31700
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING AND NO UNEXPECTED ALARMS WERE NOTED DURING TESTING. THE INSULIN PUMP HAD MULTIPLE ALARMS IN ALARM HISTORY SCREEN DUE TO CORRUPTED HISTORY FILE. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS RECEIVING SEVERAL ALARMS ON THEIR INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611446 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1