BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 3143587 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-01041
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE OCCURRED ON ONE SPECIFIC SPECIMEN. THE SAMPLE WAS COLLECTED AS WHOLE BLOOD; NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER ON SAMPLE COLLECTION OR ANALYSIS. CONTROLS RECOVERED WITHIN SPECIFICATION PRIOR TO THE INCIDENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 FOR THIS EVENT. THE FSE OBSERVED INCOMPLETE COMPUTATION VALUES ON STARTUP AND DURING RUNS. THE FSE ALSO VERIFIED THAT THE HGB BLANK VALUES WERE NOT MATCHING. THE FSE REPLACED THE HGB LAMP WHICH RESOLVED THE ISSUE. THE FSE RAN CONTROLS AND CALIBRATED THE HGB PARAMETER. ALL CONTROLS RECOVERED WITHIN LABORATORY SPECIFICATION. SERVICE ACTIVITY WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. FAILURE MODE IS RELATED TO A FAULTY HGB LAMP. THE INSTRUMENT GENERATED HGB VOLTAGE ERRORS AND INCOMPLETE COMPUTATION FOR HGB INTERMITTENTLY ALERTING THE CUSTOMER OF AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING ONE (1) PATIENT RECOVERED WITH AN ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULT GENERATED ON THE COULTER AC*T DIFF 2 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE ANALYZER ALSO GENERATED VOLTAGE ERRORS AND INCOMPLETE COMPUTATION FOR HGB ON STARTUP AND SAMPLES INTERMITTENTLY. THE CUSTOMER IS ONLY QUESTIONING ONE (1) PATIENT SAMPLE AT THIS TIME. THE ORIGINAL SAMPLE YIELDED A HGB RESULT OF 7.0 G/DL. THE RESULT WAS NOT BELIEVABLE SO THE SAMPLE WAS RERUN AND YIELDED A RESULT OF 10.0 G/DL, WHICH WAS REPORTED. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243734 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1