BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4241454 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-48599
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO PROTRUDED OR LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM OCCLUSION, PRIME, THE EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE NEAR RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND MISSING END CAP STICKER. 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 INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722303 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1