BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED 670G

    MDR report key: 6169300 · Received December 6, 2016

    Report

    Report Number
    MW5066653
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    December 2, 2014
    Report Date
    December 6, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    (B)(4) DOCK TO STOCK, SELECTION PROCESS OBSOLETE (B)(6) 2014. DOCK TO STOCK STILL ACTIVE IN SAP SYSTEM AND USER DECISION MADE BY BATCH AND 370 LOT HAS BEEN PROCESS THRU SAP WITHOUT INSPECTION RECORD. NO INSPECTION RECORD DOCUMENTED AND MATERIAL RELEASED BY ELECTRONIC SYSTEM IN SAP TO PRODUCTION. BATCH# LISTED BELOW: 5084820 A00033558, 5085199 5078002 5084141 5078003 5086930 5084752 5079839 5079837 5079836 5085200 5079841 5079843 5079844 5087362 5071977 5092794 5092795 A000338669 A000339112 A000339598 5087364 5088919 5088918 5088920 5078004 5083710 A000342741 5094267 5088921 5092800 5071978 A000344264 5088922 5101573 5094285 5094287 5094270 5092799 5094288 5098588 5098589 A000345491 5103359 5094271 5094282 A000346053 5094281 5098582 5094263 A000347218 5098764 5094266 5105587 A000347855 5099538 5101204 5105369 5098586 5105588 5094264 5105582 5105591 A000351013 5105583 5098591 5098584 5108089 5113961 5105594 5098592 5108078 5102035 5108026 5105585 5098587 5108078 5108091 5108076 5108083 5105584 A000355769 A000355797 5108085 5115712 5108092 5108080 5120622 A000357935 A000359086 5108071 5108095 A000359677 5115714 5122420 5117785 5123577 5122419 5108087 5130778 5115709 5110126 5122421 5115702 5115700 5131872 5122420 51157035115706 5130814 A000361931 5123578 A000363508 5130741 5123579 5134515 5134852 A000365019 5134850 5132371 5138183 5134857 5130745 5137379 5123535 5135167 5138184 5135165 5132367 5134851 5140414 5140350 5135172 5140425 A000367198 A000367597 5140412 5135169 5140415 A000369534 A000369683 5144317 5148147 5144378 5141462 5144379 5141464 5144391 A000370785 5144420 A000372300 A000373089 5144381 5140413 A000373369 5151815 5141459 5144422 A000374739 5144386 5144403 5144385 A000375323 5144393 5144427 5156545 5144383 5144396 5144424.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801121 MEDTRONIC MINIMED 670G MEDTRONIC MINIMED 670G CGA MEDTRONIC MEDTRONIC MINIMED 670G LISTED

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention