BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 12 ANALYZER

    MDR report key: 3831266 · Received May 23, 2014

    Report

    Report Number
    1061932-2014-01176
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND PERFORMED FIVE SAMPLES ANALYSES ON AN ALTERNATE COULTER ACT DIFF 12 ANALYZER; HEMOGLOBIN RESULTS VARIED AT A +/- 5% DIFFERENCE. THE FSE PERFORMED MULTIPLE BLANK SAMPLE TESTS AND MONITORED THE CYCLES - NO ISSUES WERE OBSERVED. THE FSE NOTICED AIR BUBBLES AND REPLACED THE SYRINGES. THE FSE PERFORMED A CLEAN PROCEDURE, A LATEX PARTICLE-TO-SIZE APERTURE, CLOG DETECTION AND UPDATED ITS FACTOR, AND COMPLETED REPRODUCIBILITY TEST. THE FSE THEN PERFORMED PATIENTS' SAMPLE ANALYSES ON THE ORIGINAL AND ALTERNATE INSTRUMENT; HEMOGLOBIN RESULTS VARIED AT A +/- 2% DIFFERENCE. THE FSE PERFORMED SYSTEM STARTUP AND CONTROLS - ALL RESULTS PASSED WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE REAGENT SYRINGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULTS, FOR TWO PATIENTS, INVOLVING THE COULTER ACT DIFF 12 ANALYZER. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PATIENTS' SAMPLES WERE SENT TO A REFERENCE LABORATORY FOR ANALYSIS AND CORRECTED RESULTS WERE OBTAINED. THE CUSTOMER STATED QUALITY CONTROL (QC) RECOVERED WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. IN ADDITION, THE CUSTOMER-SUPPLIED DATA INDICATED DISCREPANT WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMATOCRIT (HCT), AND PLATELET (PLT) RESULTS. THE CUSTOMER INDICATED THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENTS' SAMPLES WERE COLLECTED IN ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308028 COULTER ACT DIFF 12 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1