BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711B

    MDR report key: 6871234 · Received September 15, 2017

    Report

    Report Number
    2032227-2017-48916
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 31, 2017
    Report Date
    February 3, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169662544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH BLANK DISPLAY DUE TO CORRODED ELECTRONIC ASSEMBLIES. UNABLE TO PERFORM DISPLACEMENT TEST, SELF TEST, AND CURRENT MEASUREMENTS DUE TO DISPLAY ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2017 16:23:30 PST ICE BATCH USER (BATCH_ICE) (B)(6) COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: (B)(6) TAKEN BY: HULTER2 FATHER OF PT CALLED DURING OOH. PT DIT CHANGE THA BASAL SETTINGS, WHEN HE CHECKS THE PUMP AFTER 30 MINUTES THE PUMP HAS A BLANK SCREEN. PT CHANGED THE THE BATTERY, SCREEN STILL BLANK. PUMP HAS NOG BUMPED OR DROPPED. NO RADIATION OF MRI SCAN. CHANGED PUMP BY TNT. (B)(6). TH INPUT DATE: (B)(6) 2017 WARRANTY START: 07/21/2015 WARRANTY END: 07/20/2019 BATCH - NG1098723H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648059 640G INSULIN PUMP MMT-1711B PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711B HG12CN8 00643169662544

    Patients

    Seq Age Sex Outcome Treatment
    1