BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 8392997 · Received March 5, 2019

    Report

    Report Number
    3004209178-2019-62821
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST AND SELF TEST. NO UNEXPECTED INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR ALARM AND THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM NOTED DURING TESTING. HOWEVER, FOUND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR ALARM AND THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM IN THE HISTORY FILE DUE TO SOFTWARE ERROR.

    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO AS WELL AS THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 98 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185869 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K

    Patients

    Seq Age Sex Outcome Treatment
    1