BEUDAMED
    FDA Adverse Event Death Summary report: N

    BECKMAN COULTER MD8

    MDR report key: 323395 · Received March 13, 2001

    Report

    Report Number
    1023939-2001-00001
    Event Type
    Death
    Date Received
    March 13, 2001
    Report Date
    March 9, 2001
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER HAS REQUESTED INFO REGARDING OPERATIONAL AND HISTORICAL INFO ON THE MD8 INSTRUMENT AS PART OF THEIR INTERNAL INVESTIGATION RELATED TO A PT DEATH. NO CUSTOMER COMPLAINT OR NOTIFICATION TO THE MFR WAS MADE AT THE TIME OF THE EVENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO, HOWEVER, NO INFO HAS BEEN PROVIDED BY THE USER THAT INDICATES THAT THIS INSTRUMENT MAY HAVE BEEN ASSOCIATED WITH THE EVENT. INSUFFICIENT INFO IS AVAILABLE TO ADEQUATELY INVESTIGATE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11235 BECKMAN COULTER MD8 CLINICAL HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. COULTER MD8 INSTRUMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death