BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER AC T DIFF 2 ANALYZER

    MDR report key: 872674 · Received June 27, 2007

    Report

    Report Number
    1061932-2007-00036
    Event Type
    Other
    Date Received
    June 27, 2007
    Date of Event
    May 26, 2007
    Report Date
    June 27, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE A DAY AND IT WAS RUN BEFORE THE EVENT. PER CUSTOMER, QC WAS WITHIN SPECIFICATIONS AT THE TIME OF THIS EVENT. DURING THE EVENT, THE INSTRUMENT WAS OPERATING IN AN OPEN VIAL, WHOLE BLOOD MODE. THE SPECIMEN WAS COLLECTED VIA A FINGER STICK INTO A 250UL CONTAINER. THE ERRONEOUS RESULT OCCURRED ON A SPECIFIC SAMPLE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: A) THE FSE REVIEWED PATIENT DATABASE AND QC FILES. B) THE FSE PERFORMED REPRODUCIBILITY WITH VENOUS AND FINGER STICK SAMPLES. C) THE FSE REPLACED VACUUM ISOLATION CHAMBER. D) THE FSE RAN STARTUP AND QC WITH ACCEPTABLE RESULTS. E) THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND ALL RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. AS OF 06/09/07, THERE HAVE BEEN NO REPORTS OF RESULTS NOT MATCHING REFERENCE INSTRUMENT FROM THIS ACCOUNT. 7. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW HEMOGLOBIN (HGB) AND PLATELET (PLT) RESULTS GENERATED BY THE COULTER AC T DIFF 2 INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR HGB AND PLT AND RESULTS OF 5.4G/DL AND 108 X 10 TO THE POWER OF 3 CELLS/UL WERE OBTAINED RESPECTIVELY. BOTH RESULTS WERE PRINTED WITH AN "L" FLAG. ("L" - "FOR PATIENT SAMPLES, RESULT IS LOWER THAN THE LOW PATIENT SAMPLE LIMIT. FOLLOW YOUR LABORATORY'S PROTOCOL".) THE RESULTS WERE REPORTED OUT OF THE LAB AND THE PATIENT WAS SENT TO A HOSPITAL. THE PATIENT SAMPLE WAS TESTED AT THE HOSPITAL'S LAB FOR HGB AND PLT AND HIGHER RESULTS WERE OBTAINED FOR BOTH ANALYTES: HGB RESULT WAS 13.4G/DL. PLT RESULT WAS 315 X 10 TO THE POWER OF 3 CELLS/UL. THERE WAS NO AFFECT TO PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC T DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR