BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 8238996 · Received January 11, 2019

    Report

    Report Number
    3004209178-2019-43841
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    January 7, 2019
    Report Date
    June 24, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169999770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    DEVICE PASSED ALL FUNCTIONAL TESTS INCLUDING DISPLACEMENT, AND SELF TESTS. NO THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM ERROR OR INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR ALARM WERE NOTED DURING TESTING. NEITHER THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM ERROR NOR INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR ALARM ARE FOUND IN THE DEVICE HISTORY FILE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO AND THE ONE-MINUTE NON-DESTRUCTIVE RAM TEST FAILED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FRO ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33420 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG21KGH 00643169999770

    Patients

    Seq Age Sex Outcome Treatment
    1