BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWH

    MDR report key: 8747833 · Received July 1, 2019

    Report

    Report Number
    2032227-2019-23346
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    July 1, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED UNABLE TO PERFORM THE DISPLACEMENT DUE TO COMPLETE BROKEN RESERVOIR TUBE LIP NOTED. THE P-CAP NOT LOCKS INTO THE RESERVOIR COMPARTMENT PROPERLY DUE TO COMPLETELY BROKEN RESERVOIR TUBE LIP 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 HAD IWR HARDWARE DAMAGED. "CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT." THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542566 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWH PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWH 00643169507609

    Patients

    Seq Age Sex Outcome Treatment
    1