BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2180999 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00797
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A 5 ML VACUTAINER TUBE AND SAMPLED WITHIN 10 MINS OF COLLECTION. THE SPECIMEN WAS HAND MIXED. THE INSTRUMENT WAS WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. CONTROLS WERE RUN BEFORE THIS INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. ON (B)(4) 2010, A FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND VERIFIED THE INSTRUMENT'S OPERATION. THE FSE RERAN THE SPECIMEN IN SECONDARY MODE AND OBTAINED CORRECT RESULTS. PRODUCT LABELING INDICATES THAT WHEN A PARTIAL ASPIRATION ERROR MESSAGE OCCURS, THE OPERATOR IS TO ENSURE SAMPLE VOLUME AND RERUN THE SPECIMEN. IF THE ERROR RECURS, THEN RERUN SPECIMEN IN THE MANUAL MODE, CLEAN THE ASPIRATION SYSTEM AND RERUN THE SPECIMEN. IF THE ERROR PERSISTS CALL BECKMAN COULTER, INC. THE ROOT CAUSE IS UNK. THE LH500 INSTRUMENT FLAGGED THE PT RESULTS WITH SUSPECT FLAGS AND PARTIAL ASPIRATION FLAGS THAT PROMPT THE OPERATOR TO FURTHER REVIEW THE SAMPLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW COMPLETE BLOOD COUNT (CBC) RESULTS FOR ONE PT WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY AFTER MULTIPLE RERUNS. THE PHYSICIAN QUESTIONED THE RESULTS AND THE PT WAS SENT TO ANOTHER LABORATORY FOR REPEAT TESTING. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO THE RESULTS OBTAINED AT THE OTHER LABORATORY. HIGHER CBC RESULTS WERE OBTAINED AT THE OTHER LABORATORY. A CORRECTED REPORTED WAS ISSUED. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 500 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK