BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 8665640 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11055
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 27, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169999770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY. UNABLE TO DETERMINE THE ROOT CAUSE, PROBLEM ISOLATED TO ELECTRICAL BOARD. NO PHYSICAL DAMAGE TO THE INSULIN PUMP NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WAS DROPPED ON THE GROUND AND THE SCREEN DID NOT OPERATE ALSO THE INSULIN PUMP COULD NOT BE OPERATED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462024 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG38DK6 00643169999770

    Patients

    Seq Age Sex Outcome Treatment
    1