BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4251892 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-53026
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM OCCURRED DURING BASIC OCCLUSION TEST, DUE TO PROTRUDED OR LOOSE DRIVE SUPPORT DISK. IT WAS NOT POSSIBLE TO PERFORM COMPLETE TESTING, DUE TO THE MOTOR ERROR ALARM. THE MOTOR WAS TESSED OUTSIDE THE DEVICE AND PASSED THE MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED RESERVOIR TUBE NEAR RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT, AND A MISSING END CAP STICKER. AND CRACKED RESERVOIR TUBE LIP. 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 THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736709 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1