BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 8681720 · Received June 10, 2019

    Report

    Report Number
    2032227-2019-13486
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    June 4, 2019
    Report Date
    October 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000187422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE POWER UP PROPERLY AFTER BATTERY INSTALLATION. DEVICE RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. DEVICE PASSED SELF TEST, REWIND, PRIME OR SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO CRITICAL PUMP ERROR ALARMS NOTED. NO DAMAGE ON ELECTRONIC ASSEMBLIES NOTED. (B)(4).

    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. 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

    IT WAS REPORTED THAT THEY RECEIVED THE OPEN BOOK IMAGE ON THE INSULIN PUMP SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING STEPS WERE PROVIDED FOR OPEN BOOK IMAGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477660 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG37A25 00763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1