BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® AC T 5DIFF CP ANALYZER

    MDR report key: 3150833 · Received June 6, 2013

    Report

    Report Number
    1061932-2013-01092
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K003677
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND LUBRICATED THE TRAVERSE ASSEMBLY GUIDE BARS AND ADJUSTED THE TRAVERSE PROBE PISTONS. SERVICE ACTIVITY WAS PERFORMED AND WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. FAILURE MODE WAS RELATED TO A RIGID TRAVERSE ASSEMBLY AND INCORRECTLY ALIGNED TRAVERSE PROBE PISTONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ERRONEOUS HEMOGLOBIN (HGB) AND RED BLOOD COUNT (RBC) RESULTS HAD BEEN RECOVERED ON TWO (2) PATIENT SAMPLES RUN ON THE COULTER AC T 5DIFF CP ANALYZER. THE PATIENT SAMPLES WERE TESTED ON ANOTHER INSTRUMENT, THE HEMOCUE, AND OBTAINED RESULTS WERE CONSIDERED CORRECT. CORRECT RESULTS HAVE NOT BEEN PROVIDED BY THE CUSTOMER. PER THE CUSTOMER, ONE OF THE SAMPLES RECOVERED HGB RESULT OF 5.6 G/DL. THE CUSTOMER RERAN THE SAME SAMPLE AND OBTAINED A HGB RESULT OF 11.2 G/DL. RESULTS FOR BOTH PATIENTS WERE REQUESTED BUT ONLY ONE PATIENT RESULTS HAVE BEEN PROVIDED. ON THE ORIGINAL PRINTOUTS RECEIVED FROM THE CUSTOMER, THE HGB RESULT FOR THE INITIAL RAN (12.2 G/DL) DID NOT CORRELATE WITH THE RESULT REPORTED BY THE CUSTOMER. THE REPEAT HGB RESULT WAS NOT VISIBLE ON THE PRINT OUT. RESULTS WERE AGAIN REQUESTED FROM THE CUSTOMER TO PROVIDE CLARIFICATION; HOWEVER, THIS PROVED UNSUCCESSFUL AS THE CUSTOMER STATED THE RESULTS AND PRINTOUTS WERE NO LONGER AVAILABLE FROM THE INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO DEATH; HOWEVER, ONE OF THE TWO PATIENTS WAS GIVEN TWO UNITS OF BLOOD AS A RESULT OF THE ERRONEOUS LOW HGB RESULT. THIS MDR IS TO FILE AN ADVERSE EVENT REPORT FOR THE PATIENT WHO WAS TRANSFUSED WITH THE TWO UNITS OF BLOOD AS A RESULT OF THIS EVENT. TWO MDRS ARE BEING SUBMITTED FOR THIS EVENT: 1061932-2013-01091 (INSTRUMENT MALFUNCTION), 1061932-2013-01092 (ADVERSE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251002 COULTER® AC T 5DIFF CP ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT 5DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other