BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 SLIDEMAKER

    MDR report key: 2389743 · Received December 28, 2011

    Report

    Report Number
    1061932-2011-02686
    Event Type
    Malfunction
    Date Received
    December 28, 2011
    Date of Event
    November 27, 2011
    Report Date
    November 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT CARRY-OVER FOR BOTH THE INSTRUMENT RESULTS WERE WELL WITHIN NORMAL LIMITS. THE SAMPLES ARE COLLECTED IN 5ML EDTA AND SAMPLED <12 HOURS LATER. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS ARE RUN TWICE DAILY. PER THE CUSTOMER COMPLAINT RECORD, CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND COULD REPRODUCE CARRYOVER WHEN NO PRIME WAS RUN. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED THE TECHNICAL UPDATES FOR SLIDEMAKER CARRY-OVER ISSUES (ACTIONS NEEDED TO REDUCE SLIDEMAKER ELEVATED CARRY-OVER LEVELS) AND VERIFIED THE INSTRUMENT'S OPERATIONS. THE ROOT CAUSE IS UNKNOWN, BUT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS TO FOLLOW THE CONTROL BLOOD WITH ONE PRIME BLOOD AS STATED IN LABELING. PER LABELING, BECKMAN COULTER'S TESTING HAS DETERMINED WITHIN 95% CONFIDENCE LIMITS, ZERO TO ONE CELL MAY BE CARRIED OVER TO THE WORKING AREA OF A SUBSEQUENT PATIENT SAMPLE SLIDE AT A WBC LEVEL OF 90 X 103/UL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT TWO (2) LH 750 SLIDEMAKERS SHOWED CARRY-OVER IMMEDIATELY AFTER THE CONTROL SAMPLE WAS RUN AND CARRY-OVER BLASTS INTO NORMAL PERIPHERAL FILMS WERE SHOWN ON PATIENT SPECIMENS IMMEDIATELY AFTER SPECIMENS THAT INCLUDE BLAST CELLS WERE RUN. THE CUSTOMER RAN CONTROLS ON BOTH INSTRUMENTS FOLLOWED BY NORMAL SAMPLES AND AVIAN CELLS WERE SEEN ON BOTH INSTRUMENTS. THIS REPORT IS DOCUMENTING INSTRUMENT S/N (B)(4). THE OTHER INSTRUMENT S/N (B)(4) IS DOCUMENTED IN MDR 1061932-2011-02743. THE CUSTOMER THEN RAN TWO (2) DIFFERENT PATIENT SAMPLES, YIELDING A VALUE FOR WHITE BLOOD COUNT (WBC) OF 1.7 AND 15% BLASTS FOR THE FIRST SAMPLE; A BLAST WAS SEEN ON THE FOLLOWING SLIDE OF A NORMAL PATIENT. THE SECOND PATIENT SAMPLE YIELDED A WBC RESULT OF 30 WITH 45% BLASTS; 2 BLASTS WERE SEEN ON THE FILM OF THE NORMAL PATIENT THEY RAN. THE (2) TWO BLAST SAMPLES FOLLOWED BY THE NORMAL SAMPLES THE CUSTOMER PERFORMED AS AN EXPERIMENT TO CHECK FOR CARRY-OVER. THIS DID NOT HAPPEN ON A PATIENT SAMPLE THE CUSTOMER WAS EXPECTING TO REPORT. THAT IS, THE BLAST CARRY-OVER SEEN WAS AS A TEST AND NOT REAL PATIENT RUNS. NO ERRONEOUS RESULTS WERE REPORTED OUT AND THERE WAS NO CHANGE TO PATIENT TREATMENT. THE CUSTOMER BELIEVES THAT BEC SERVICE MAY NEED TO LOOK AT THE WASH STATION ON THE SLIDE MAKER BETWEEN SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 SLIDEMAKER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 750 SLIDEMAKER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1