BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF CP

    MDR report key: 2993004 · Received March 7, 2013

    Report

    Report Number
    1061932-2013-00308
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CONFIRMED THE REPORTED PROBLEM WITH THE HGB PARAMETER AND REPLACED THE HGB PHOTOMETER ASSEMBLY. THE FSE ALSO ALIGNED PROBE POSITION AND VERIFIED THE ANALYZER. THE FAILURE MODE OF THIS EVENT WAS ATTRIBUTED TO THE HGB PHOTOMETER ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT HEMOGLOBIN (HGB) RESULTS FOR ONE PATIENT SAMPLE, OBTAINED ON THE COULTER ACT 5 DIFF CP, WERE NOT MATCHING UPON RERUN ON THE SAME INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, AND THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PER THE LABORATORY PROTOCOL, THE CUSTOMER RERUNS ALL HGB RESULTS THAT FAIL THE PATIENT'S ESTABLISHED DELTA CHECK AND OR ANY HGB RECOVERED VALUE OF 10.0 OR BELOW. DATA PROVIDED BY THE CUSTOMER INDICATED THAT THE INITIAL SAMPLE RESULTS CORRELATED WITH THE RESULTS FROM RERUN 2, WHICH THE CUSTOMER CONSIDERED CORRECT. THE RESULTS FROM RERUN 1 WERE CONSIDERED INCORRECT AND RECOVERED LOWER FOR THE FOLLOWING PARAMETERS: RED BLOOD COUNT (RBC), HGB, AND HEMATOCRIT (HCT) COMPARED TO RERUN 2. CONTROLS RUN BEFORE THIS EVENT RECOVERED WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98266 COULTER® AC T 5DIFF CP COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC T 5DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1