BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF CP ANALYZER

    MDR report key: 3160240 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-00998
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K003677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND REPLACED A DETERIORATED WHITE BLOOD CELL (WBC) LYSE REAGENT TUBING AND VERIFIED REPAIRS. PER PHONE CONVERSATION WITH THE CUSTOMER ON (B)(4) 2013, THE INSTRUMENT HAS HAD NO FURTHER ISSUES. THE CAUSE OF THE RESULT DISCREPANCY WAS RELATED TO A DETERIORATED WBC LYSE REAGENT TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ERRONEOUS HEMOGLOBIN (HGB) RESULTS HAD BEEN OBTAINED FOR TWO (2) SAMPLES RUN ON THE COULTER AC T 5DIFF CP ANALYZER, COMPARED TO THE RESULTS OBTAINED FROM THE SAME SAMPLES TESTED BY THE REFERENCE LABORATORY, WHICH WERE CONSIDERED CORRECT. THE CUSTOMER INSPECTED THE INSTRUMENT AND FOUND THAT THE TUBING TO THE WHITE BLOOD COUNT (WBC) LYSE REAGENT BOTTLE HAD BECOME DISCONNECTED. THE CUSTOMER PROCEEDED TO RECONNECT THE TUBING AND PRIMED THE REAGENT RERUNNING THE SAME SAMPLE (SAMPLE A) SEVERAL TIMES. RERUN RESULTS WERE NOT CONSIDERED CORRECT. FOR TROUBLESHOOTING PURPOSE, THE CUSTOMER ALSO RAN ANOTHER SAMPLE (SAMPLE B), AFTER COMPLETING A BACKFLUSH AND A MINIPRIME PROCEDURE. ALL RESULTS OBTAINED FROM SAMPLE B WERE NOT CONSIDERED CORRECT. DATA PROVIDED BY THE CUSTOMER FOR REVIEW REVEALED THAT INITIAL RESULTS FOR SAMPLES A AND B RECOVERED LOWER WHITE BLOOD COUNT (WBC) AND PLATELET (PLT), AND HIGHER RED BLOOD COUNT (RBC), HGB AND HEMATOCRIT (HCT) RESULTS WITH INSTRUMENT GENERATED SUSPECT MESSAGES, COMPARED TO RESULTS OBTAINED FOR BOTH SAMPLES FROM THE REFERENCE LABORATORY, WHICH WERE REPORTED AS CORRECT. THE TWO SAMPLES WERE RERUN EACH A TOTAL OF THREE TIMES. ERRATIC RESULTS WERE OBTAINED FOR BOTH ON RERUN 1; HOWEVER, RERUN RESULTS 2 AND 3 FROM BOTH SAMPLES, ALTHOUGH NOT REPORTED AS CORRECT, CORRELATED WITH RESULTS OBTAINED FROM THE REFERENCE LABORATORY. PATIENT RESULTS ARE PROVIDED IN FILE ATTACHMENT. THE CUSTOMER INDICATED THAT A SAMPLE WITH A VERY HIGH HGB (SAMPLE A) WAS REPORTED OUT OF THE LABORATORY AND RESULTS WERE LATER QUESTIONED BY THE PHYSICIAN. ALTHOUGH THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, THERE WAS NO DEATH OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260483 COULTER® AC T 5DIFF CP ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT 5DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR