BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711W

    MDR report key: 8665460 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-10939
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169662582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STUCK BUTTON ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 7.2 MMOL/L AT THE TIME OF INCIDENT. CUSTOMER STATES IT WAS POSSIBLE IT MAY HAVE BEEN PRESSED FOR 3 MIN OR LONGER. CUSTOMER STATES THEY WERE NOT ABLE TO CLEAR THE ALARM. CUSTOMER STATED THE BUTTONS WERE STOPPED WORKING COMPLETELY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462012 640G INSULIN PUMP MMT-1711W PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711W HG10GWV 00643169662582

    Patients

    Seq Age Sex Outcome Treatment
    1