BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2353505 · Received November 30, 2011

    Report

    Report Number
    1061932-2011-02397
    Event Type
    Malfunction
    Date Received
    November 30, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WERE NOT PROVIDED FOR THIS EVENT. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT AND RECOVERED WITHIN ACCEPTABLE LIMITS. THE RAW DATA PROVIDED BY THE CUSTOMER SUGGESTED THE FOLLOWING: DEBRIS INTERFERENCE PATTERNS ON THE WHITE BLOOD COUNT (WBC) HISTOGRAMS FOR THE SAMPLES INDICATED EITHER LARGE/GIANT PLATELETS OR PLATELET CLUMPS. THE SAMPLES WERE FLAGGED EITHER AS GIANT PLATELET, PLATELET CLUMP, OR SYSTEM MESSAGE "THROMBOCYTOPENIA". A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT AND CLEANED THE WBC APERTURES AND VERIFIED THE SYSTEM PERFORMANCE. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE ROOT CAUSE OF THE ERRONEOUS RESULTS HAVING BEEN REPORTED FROM THE LABORATORY IS USE ERROR. THERE WERE INSTRUMENT GENERATED FLAGS TO ALERT THE OPERATOR TO REVIEW THE RESULTS. PER BECKMAN COULTER INC. PRODUCT LABELING: THE LH 700 SERIES APPLIES INSTRUMENT-GENERATED AND/OR LABORATORY-DEFINED FLAGS, CODES, AND/OR MESSAGES TO EACH SET OF PATIENT RESULTS. FLAGS, CODES, SUSPECT AND DEFINITIVE MESSAGES ARE USED TO ALERT YOU TO AN INSTRUMENT MALFUNCTION, SPECIMEN ABNORMALITY, ABNORMAL DATA PATTERN, OR ABNORMAL RESULTS. BECKMAN COULTER RECOMMENDS REVIEW, APPROPRIATE TO YOUR PATIENT POPULATION, OF ALL RESULTS DISPLAYING A FLAG, CODE OR OTHER MESSAGE. KNOWN LIMITATIONS AND INTERFERING CONDITIONS FOR PLT INCLUDE GIANT PLATELETS, PLATELET CLUMPS, WHITE CELL FRAGMENTS, ELECTRONIC NOISE, VERY SMALL RED CELLS, RED CELL FRAGMENTS. AS PART OF A RETROSPECTIVE REVIEW, THIS EVENT WAS DETERMINED TO BE REPORTABLE. ASSOCIATED MDRS: 1061932-2011-02397, 1061932-2011-02406, 1061932-2011-02411.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE BECKMAN COULTER LH 750 HEMATOLOGY ANALYZER WAS GENERATING PLATELET (PLT) RESULTS WHICH DID NOT MATCH THE MANUAL SMEAR RESULTS FOR SIX (6) PATIENT SAMPLES ON FOUR (4) DIFFERENT DAYS. THIS REPORT DOCUMENTS THE ERRONEOUS RESULTS OBTAINED ON (B)(6) 2011 FROM ONE (1) PATIENT SAMPLE. THE INITIAL ERRONEOUS PLT RESULT POSSESSED AN INSTRUMENT GENERATED FLAG, WHICH PER BECKMAN COULTER INC LABELING, NECESSITATED THE REVIEW OF RESULTS. UPON REPEAT ON THE SAME INSTRUMENT, THE PLT REPEAT RESULTS CONCURRED WITH THE INITIAL PLT RESULTS. THE REPEAT PLT RESULT ALSO POSSESSED AN INSTRUMENT GENERATED FLAG, WHICH PER BECKMAN COULTER INC LABELING, NECESSITATED THE REVIEW OF RESULTS. AN ERRONEOUS PLT RESULT WAS REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN AS TO WHICH RESULT (INITIAL, REPEAT OR BOTH) WAS RELEASED FROM THE LABORATORY. SUBSEQUENTLY, A HIGHER MANUAL PLATELET ESTIMATE WAS SENT OUT AS A CORRECTED REPORT. THERE WERE NO REPORTS OF DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1