BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWL

    MDR report key: 8105109 · Received November 27, 2018

    Report

    Report Number
    2032227-2018-67099
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    June 20, 2018
    Report Date
    November 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH CRACKED AND BLEEDING LCD DUE TO PHYSICAL DAMAGE TO LCD GLASS. UNABLE TO PERFORM OPERATING CURRENTS, SELF-TEST, UNEXPECTED RESTART ERROR TEST, AND DISPLACEMENT TEST OR VERIFY LOW BATTERY ALARM DUE TO CRACKED AND BLEEDING LCD GLASS. NO CRACKED CASE AT DISPLAY WINDOW CORNER NOTED. 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 INSULIN PUMP WAS DAMAGE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THERE WAS A CRACKS AROUND DISPLAY WINDOW. THE CUSTOMER ALSO REPORTED DIMINISHING BATTERY LIFE. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945929 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL 00643169507661

    Patients

    Seq Age Sex Outcome Treatment
    1