BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FP, BCI TC GIEMSA STAIN

    MDR report key: 2421961 · Received January 19, 2012

    Report

    Report Number
    1061932-2012-00186
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    January 1, 2010
    Report Date
    December 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    HYF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GIEMSA STAIN IS USED IN COMBINATION WITH OTHER ROMANOWSKY STAINS TO STAIN WHOLE BLOOD SMEARS PREPARED ON GLASS MICROSCOPE SLIDES IN THE LH SLIDESTAINER. THE ARE NO CLAIMS IN THE GIEMSA STAIN INSTRUCTIONS FOR USE (IFU) FOR STAIN STABILITY ON BOARD THE INSTRUMENT. PER LABELING, THE COULTER LH 750 SLIDE STAINER OPERATOR'S GUIDE STATES: BECKMAN COULTER PROVIDES NO PERFORMANCE CLAIMS FOR THIS INSTRUMENT. INFORMATION IS SUPPLIED TO THE CUSTOMERS AS REFERENCE MATERIAL ONLY AND (PERFORMANCE) IS NOT GUARANTEED BY BECKMAN COULTER. THE ISSUE IS CURRENTLY UNDER INVESTIGATION BY THE SUPPLIER. THE ROOT CAUSE IS UNKNOWN. GIEMSA STAIN, LOT NUMBER 0626169. INFORMATION FOR GIEMSA LOT NUMBER 0626170 IS PROVIDED BELOW: MANUFACTURED DATE: 03/16/2011; EXPIRATION DATE: 05/16/2011. LH750 SLIDE STAINER INFORMATION: BRAND NAME: COULTER LH 750 SLIDE STAINER. COMMON DEVICE NAME: SLIDE STAINER, AUTOMATED. PRODUCT CODE: KPA. PRODUCT CODE NAME: SLIDE STAINER, AUTOMATED. DEVICE CLASS; CLASS I; CLASSIFICATION PANEL: PATHOLOGY. C.F.R. SECTION: 864.3800- AUTOMATED SLIDE STAINER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THE INTENSITY OF THE CELL COLORATION OF PERIPHERAL BLOOD SMEARS DIMINISHES RAPIDLY CAUSING THE INABILITY TO ACCURATELY IDENTIFY WHITE BLOOD COUNT (WBC) CELL POPULATIONS ON STAINED SMEARS WHEN USING LOT NUMBERS 0626169 AND 0626170 OF THE FP, BCI TC GIEMSA STAIN ON BOARD THE COULTER LH 750 SLIDE STAINER INSTRUMENT. BASED ON AVAILABLE INFORMATION, THE CUSTOMER HAS FILED A (B)(4) REPORT WITH THE (B)(4) COMPETENT AUTHORITIES. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT AND THERE IS A REMOTE PROBABILITY THAT THE HAZARD WILL CAUSE MEDICALLY REVERSIBLE OR TRANSIENT HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FP, BCI TC GIEMSA STAIN GIEMSA STAIN HYF BECKMAN COULTER, INC. NA 0626169, 0626170

    Patients

    Seq Age Sex Outcome Treatment
    1