BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCOLOR WRIGHT'S GIEMSA STAIN KIT

    MDR report key: 2256782 · Received August 19, 2011

    Report

    Report Number
    1061932-2011-01206
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    April 22, 2010
    Report Date
    April 23, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KQC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DETERMINED THE TRUCOLOR WRIGHT'S GIEMSA STAIN KIT WAS CONTAMINATED BY PERFORMING THE FOLLOWING ACTIONS: THE CUSTOMER PLACED THE SAME LOT# OF TRUCOLOR WRIGHT'S GIEMSA STAIN KIT ON TWO LH SLIDE STAINER INSTRUMENTS. THE YEAST CELLS WERE PRESENT ON THE MANUAL SMEARS FROM BOTH OF THESE INSTRUMENTS. THE CUSTOMER ALSO CULTURED THE RINSE WATER FROM THE SLIDE STAINER INSTRUMENTS AND PERFORMED GRAM STAIN OF THE BUFFER, BOTH WERE NEGATIVE. THE CUSTOMER DECONTAMINATED THE SLIDE STAINER AND REPLACED THE STAIN WITH THE CONTAMINATED LOT# AND THE YEAST CELLS PERSISTED. THE CUSTOMER SWITCHED STAIN LOT# AND THE YEAST CELLS WERE NO LONGER PRESENT. THE PRODUCT WAS NOT RETURNED FOR EVAL. MICROBIAL CONTAMINATION OF THE STAIN HAS NOT BEEN CONFIRMED BY BECKMAN COULTER INC. THE SUSPECT STAIN LOT NUMBER CANNOT BE RETURNED FROM THE CUSTOMER DUE TO DEPT OF TRANSPORTATION REGULATIONS. ROOT CAUSE IS UNK. THE CUSTOMER REPLACED THE STAIN WITH DIFFERENT STAIN REAGENT LOT# AND NO OTHER REPORTS OF YEAST CONTAMINATION HAVE BEEN RECEIVED. A REVIEW FOR SIMILAR EVENTS WAS CONDUCTED. THERE HAVE BEEN NO OTHER REPORTS OF YEAST CONTAMINATION IN SLIDE STAIN REAGENTS FROM 2005 TO 2010. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PRESENCE OF YEAST CELLS WITH THE DIFFERENTIAL RESULTS FOR TWO PTS AFTER USING BLOOD SMEAR SLIDES THAT WERE STAINED FOR ANALYSIS WITH THE LH SLIDE STAINER AND TRUCOLOR WRIGHT'S GIEMSA STAIN KIT. THE PRESENCE OF YEAST CELLS WITH THE DIFFERENTIAL RESULTS WERE REPORTED OUT OF THE LABORATORY FOR THE TWO PTS. THE CUSTOMER DETERMINED THE SOURCE OF THE YEAST CELLS TO BE THE TRUCOLOR WRIGHT'S GIEMSA STAIN KIT. THE CUSTOMER REPORTED THAT IN ADDITION TO THE TWO PTS THAT WERE REPORTED WITH YEAST CELLS, FOUR TO FIVE ADD'L SAMPLES WERE SEEN WITH YEAST CELLS ON THE BLOOD SMEAR SLIDE PREPARED WITH THE SAME LH SLIDE STAINER AND TRUCOLOR WRIGHT'S GIEMSA STAIN KIT. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUCOLOR WRIGHT'S GIEMSA STAIN KIT KQC BECKMAN COULTER, INC. NA 609681

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LH SLIDE STAINER