BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711W

    MDR report key: 7493518 · Received May 8, 2018

    Report

    Report Number
    3004209178-2018-69812
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 19, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169739482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. DEVICE PASSED DISPLACEMENT TEST AND SELF TEST. THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO AND THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM NOTED IN FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER INSULIN PUMP HAD A THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 8.2 MMOL/L. THE CUSTOMER REPORTED THAT THEY RECEIVED THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR SECOND TIME. THE CUSTOMER WAS ADVISED TO REPLACE IN THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336276 640G INSULIN PUMP MMT-1711W PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711W HG16PB7 00643169739482

    Patients

    Seq Age Sex Outcome Treatment
    1