BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF ANALYZER

    MDR report key: 2631381 · Received June 27, 2012

    Report

    Report Number
    1061932-2012-02019
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INSTRUMENT GENERATED FLAGS WERE INDICATED FOR THE PLT PARAMETER FOR EACH OF THE PATIENTS, WITH THE EXCEPTION OF PATIENT 6. PATIENT 5 EXHIBITED LOW PLT AS WELL AS LOW HGB VALUES COMPARED TO THE REFERENCE RESULTS FOR THE SAME SAMPLE. QUALITY CONTROL (QC) DATA PROVIDED FOR THE INVESTIGATION DISPLAYED NO ABNORMALITIES IN RANGE OR LOW BIAS FOR THE PERIOD INDICATED. THE CUSTOMER TECHNICAL SPECIALIST (CTS) EVALUATED THE INSTRUMENT ISSUE BY TELEPHONE BY REVIEWING CALIBRATION AND OTHER SYSTEM DATA. THE CTS REVIEWED ALL OF THE DATA WITH CUSTOMER AFTER RECEIPT OF THE QC, CALIBRATION, REPRODUCIBILITY AND PATIENT DATA ON (B)(6) 2012, AND EXPLAINED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AS NO SIGNIFICANT DIFFERENCES WERE OBSERVED. THE CTS ALSO EXPLAINED THAT WHENEVER THE SAME SAMPLE IS CYCLED ON DIFFERENT INSTRUMENTS, THE VARIABILITY OF RESULTS MAY INCREASE DUE TO VARIED CALIBRATION FACTORS ON EACH INSTRUMENT. THE CTS FURTHER EXPLAINED NATURAL BEHAVIOR OF CONTROL RESULTS DURING OPEN VIAL LIFE. CUSTOMER REQUESTED A WRITTEN EXPLANATION DETAILING THAT THE PLT VARIANCE OBSERVED WAS NOT SIGNIFICANT. PLEASE NOTE THAT THE FOLLOWING MEDICAL DEVICE REPORTS WERE SUBMITTED TO DOCUMENT THE PATIENT RESULTS THAT CUSTOMER PROVIDED AS EXAMPLES OF THE ISSUE ON VARIED DATES: MDR #1061932-2012-01968 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02016 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02017 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02018 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02019 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02020 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02021 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02022 (BECKMAN COULTER, INC. (B)(4)); MDR #1061932-2012-02023 (BECKMAN COULTER, INC. (B)(4)).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE COULTER AC.T DIFF ANALYZER GENERATED LOW PLATELET (PLT) RECOVERY ON PATIENT SAMPLES AND ON CONTROLS. THE SPECIFIC NUMBER OF PATIENT SAMPLES AFFECTED AND THE SPECIFIC DAYS THE SAMPLES WERE REPORTED COULD NOT BE DETERMINED. HOWEVER, NINE PATIENTS RUN FROM (B)(6) 2012 WERE PROVIDED FOR THIS INVESTIGATION TO DOCUMENT THIS ISSUE. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT WERE AMENDED WHEN THE ISSUE WAS NOTICED. THERE WAS NO AFFECT TO PATIENT TREATMENT BASED ON THE ERRONEOUS RESULTS. CUSTOMER PERFORMED A CALIBRATION AND ADJUSTED THE CALIBRATION FACTOR FOR THE PLT PARAMETER, PER THE SYSTEM'S RECOMMENDATION. CUSTOMER REPEATED CELL CONTROLS AFTER CALIBRATION, AND THE PLT RECOVERY INCREASED IN COMPARISON TO PRE-CALIBRATION RESULTS. HOWEVER, CUSTOMER INDICATED THAT AFTER CALIBRATION, A KNOWN PATIENT SAMPLE, USED TO CONFIRM INSTRUMENT FUNCTION ON (B)(6) 2012, RECOVERED ABNORMALLY LOW PLT RESULTS, WITH A COUNT OF 105, WHICH PROMPTED CUSTOMER TO CALL BECKMAN COULTER. THE PHYSICIAN SUSPECTED THAT THE RESULTS WERE ERRONEOUS BECAUSE THE PATIENT RESULTS DID NOT MATCH THE PATIENT'S CLINICAL PROFILE / HISTORY, AND THE VALUES WERE BELOW THE LABORATORY'S NORMAL PLT COUNT RANGE OF 140 TO 415. CUSTOMER STATED THAT SOME OF THE PATIENT SAMPLES THAT WERE QUESTIONED BY THE PHYSICIAN WERE SENT TO A REFERENCE LABORATORY FOR RE-ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1