BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3028301 · Received April 1, 2013

    Report

    Report Number
    1061932-2013-00440
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) WAS RUN BEFORE THE EVENT AND RESULTS WERE WITHIN SPECIFICATIONS. PATIENT CONTROL WAS RUN ONE HOUR PRIOR TO THE SAMPLE TESTING AND WAS ACCEPTABLE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO (ACCURACY) AND REPRODUCIBILITY (PRECISION). RAW DATA FILES WERE NOT COLLECTED FOR THE INSTRUMENT. THERE WAS NO SERVICE DISPATCHED FOR THIS EVENT. PER LABELING: BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER SUGGESTS USING ALL AVAILABLE OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS. FAILURE MODE IS UNKNOWN BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT TWO (2) COULTER LH 750 HEMATOLOGY ANALYZERS (SERIAL NUMBER: (B)(4)) AT A SISTER ACCOUNT, WERE USED TO CONFIRM ERRONEOUS DIFFERENTIAL RESULTS FOR A SINGLE PATIENT REPORTED VIA THE ORIGINAL RELATED COMPLAINT, MDR: 1061932-2013-00326 (FOR DXH800 INSTRUMENT), AND SIMILAR ERRONEOUS RESULTS WERE OBTAINED ON BOTH LH750 INSTRUMENTS. THIS MDR COVERS THE DIFFERENTIAL RESULTS GENERATED BY THE LH 750 ANALYZER, SERIAL NUMBER (B)(4). THE SAMPLE WAS APPROXIMATELY 36 HOURS OLD WHEN ANALYZED ON THE TWO LH750 INSTRUMENTS. REVIEW OF PATIENT DATA SHOWED SIMILAR ERRONEOUS RESULTS WERE OBTAINED ON BOTH LH750 INSTRUMENTS, COMPARED TO THE MANUAL DIFFERENTIAL RESULTS (CORRECT), WITH NO INSTRUMENT GENERATED FLAGS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE 2 LH 750 INSTRUMENTS WERE USED ONLY FOR CONFIRMATORY TESTING. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT. MDR 1061932-2013-00441 IS BEING SUBMITTED FOR LH 750 INSTRUMENT, SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131696 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1