BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DEH

    MDR report key: 8716180 · Received June 20, 2019

    Report

    Report Number
    2032227-2019-19289
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    September 28, 2018
    Report Date
    June 20, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169400955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/COMPROMISED FORCE SENSOR SYSTEM TEST AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARMS. 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. THE ASR EXEMPTION E2015043 WAS REVOKED ON FEBRUARY 4, 2019. THIS EVENT WAS PREVIOUSLY REPORTED AS AN ASR. ADDITIONAL INFORMATION OR ANALYSIS RESULTS REGARDING THIS EVENT WILL BE REPORTED AS AN MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED AN OCCLUSION DUE TO PRESSION IN THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512799 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DEH PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754DEH 00643169400955

    Patients

    Seq Age Sex Outcome Treatment
    1