BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3150831 · Received June 6, 2013

    Report

    Report Number
    1061932-2013-00993
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONFIRMED THAT QUALITY CONTROL (QC) WAS ACCEPTABLE ON THE DAY OF THE EVENT AND OTHER PATIENT SAMPLES WERE ANALYZED WITHOUT ISSUES. BECKMAN COULTER SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED. THE CAUSE OF THE PLATELET (PLT) RESULT DISCREPANCY CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. DATA REVIEW SHOWS THAT REPEAT RESULTS CORRELATED WITH THE PATIENT'S HISTORY OF LOW PLT RESULTS. BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER INC. SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON THE LABORATORY'S PATIENT POPULATION. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), ACTION AND CRITICAL LIMITS, DEFINITIVE FLAGS, SUSPECT FLAGS, PARAMETER CODES, DELTA CHECKS, DECISION RULES AND SYSTEM ALARMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ERRONEOUS HIGH PLATELET (PLT) RESULT WAS GENERATED ON A SINGLE PATIENT SAMPLE IN THE AUTOMATIC MODE WHEN TESTED ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE SAMPLE WAS RE-RUN IN MANUAL MODE ON THIS INSTRUMENT AND A MANUAL SMEAR WAS MADE OF THE PATIENT SAMPLE; BOTH RESULTS WERE CONSIDERED CORRECT. MANUAL SMEAR RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED THAT THE PLT RESULT OBTAINED ON THE LH750- ANALYZER IN AUTOMATIC MODE WAS SIGNIFICANTLY HIGHER WHEN COMPARED TO THE RESULT OBTAINED WHEN RE-RUN ON THE SAME LH750 ANALYZER IN MANUAL MODE AS WELL AS ANOTHER LH750 ANALYZER IN THE MANUAL MODE. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO DEATH OR EFFECT TO PATIENT TREATMENT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251237 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR