BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 7997506 · Received October 23, 2018

    Report

    Report Number
    2032227-2018-48252
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Date of Event
    October 7, 2018
    Report Date
    February 13, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169999770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 PARADIGM REAL-TIME 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

    HARDWARE LOW LEVEL FAILURES CONFIRMED IN DOWNLOADED HISTORY LOG DUE TO A PIO (SOFTWARE) FAILURE. PUMP FAILED THE SELF TEST AND PASSED THE DISPLACEMENT TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD HARDWARE LOW LEVEL FAILURES ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 126 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER PERFORMED SELF-TEST AND IT DID NOT PASS AND AGAIN PUMP ERROR OCCURRED. THE DEVICE WILL BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835867 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG23NPR 00643169999770

    Patients

    Seq Age Sex Outcome Treatment
    1