BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 7644707 · Received June 28, 2018

    Report

    Report Number
    3004209178-2018-85956
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    November 30, 2017
    Report Date
    June 28, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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

    DIABETES CASE MANGER REPORTED VIA PHONE CALL DEMONSTRATION DEVICE NOT WORKING. TROUBLE SHOOTING WAS PERFORMED AND FOUND HALF THE SCREEN GOES OFF AND THE INSULIN PUMP RESETS ITSELF. THE DEVICE IS CURRENTLY USED ON HUMANS WITH SALINE SOLUTION. THE DISPLAY IS CURRENTLY NOT BLANK BUT HALF THE SCREEN IS MISSING. ADVISED THE INCIDENT WILL BE DOCUMENTED AND THE RS NR REPRESENTATIVE WILL BE SENT A MESSAGE PER DOP114-678 VERSION J TO REPLACE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488325 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG1QBAH 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1