BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 3962212 · Received July 28, 2014

    Report

    Report Number
    1061932-2014-01759
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND IDENTIFIED THE CAUSE WAS RELATED TO BLOOD LEFT ON THE OUTSIDE OF THE PROBE. DURING REPRODUCIBILITY, THE FIRST HEMOGLOBIN TEST RESULT WAS HIGH AND IF INSTRUMENT WAS SITTING FOR 10 + MINUTES, THE HEMOGLOBIN VALUES WOULD INCREASE. WHEN SAMPLES WERE RUN BACK TO BACK, REPRODUCIBILITY WAS GOOD WITH LOW %CV. THE FSE ALSO NOTED RESIDUAL BLOOD ON THE OUTSIDE OF THE PROBE AFTER THE PROBE WIPE RINSE. ON (B)(4) 2014, THE FSE REPLACED THE SYRINGE ASSEMBLY, PERIPUMP TUBING AND VALVES LV7, LV8, LV11 AND LV12 TO ADDRESS THE CAUSE. THIS MDR IS RELATED TO MDR 1061932-2014-01758.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS HIGH HEMOGLOBIN TEST RESULTS WERE RECOVERED FOR ONE PATIENT SAMPLE ON (B)(6) 2014 WHEN USING THE COULTER ACT DIFF ANALYZER. THE TEST RESULTS WERE CONSIDERED TO BE ERRONEOUS WHEN COMPARED TO RESULTS FROM THE SAME SAMPLE RERUN ON ANOTHER INSTRUMENT AT A REFERENCE LABORATORY, WHICH WERE CONSIDERED CORRECT. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE QUESTIONED BY THE PHYSICIAN AND RETESTED ON (B)(6) 2014. THE PHYSICIAN DETERMINED THAT BASED ON THE RETEST RESULT OBTAINED ON (B)(6) 2014, A TRANSFUSION WAS REQUIRED. THE PATIENT TRANSFUSION WAS DELAYED 24 HOURS AS A RESULT OF THE INCORRECT INITIAL RESULTS. WHEN CONTACTED ON (B)(6) 2014, THE CUSTOMER STATED THAT THE PATIENT'S CONDITION WAS BEING MONITORED AND THERE HAVE BEEN NO ADVERSE REACTION TO THE TRANSFUSION. THERE WAS NO DEATH OR SERIOUS INJURIES WERE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439344 COULTER ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1