BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711B

    MDR report key: 7965865 · Received October 15, 2018

    Report

    Report Number
    2032227-2018-42949
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 26, 2016
    Report Date
    October 15, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000643169554917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G 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 INSULIN PUMP HAD BROKEN BELT CLIP RAIL. THE INSULIN PUMP RECEIVED WITH BLANK FLASHING WHITE DISPLAY. THE INSULIN PUMP HAD BLANK FLASHING WHITE LCD DUE TO CRACKED LCD CONTROLLER. UNABLE TO PERFORM THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND DISPLACEMENT TEST DUE TO BLANK FLASHING WHITE LCD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 9.9 MMOL/L. CUSTOMER ADVISED THE INSULIN PUMP WAS CRACKED. 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
    807229 640G INSULIN PUMP MMT-1711B PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711B 000643169554917

    Patients

    Seq Age Sex Outcome Treatment
    1