BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2454794 · Received February 16, 2012

    Report

    Report Number
    1061932-2012-00395
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER QUESTIONED THE RESULTS WHEN THE LABOR AND DELIVERY DEPARTMENT (L&D) COMPLAINED THE PLATELET COUNTS WERE LOW. INITIALLY, THE CUSTOMER'S PROCEDURE CALLED FOR A MANUAL SLIDE REVIEW IF RESULTS WERE FLAGGED AND THE PLATELET RESULTS WERE LESS THAN 50,000 CELLS/UL. SUBSEQUENT TO THE COMPLAINT FROM L&D ON (B)(4) 2011, THE CUSTOMER HAD BEEN PERFORMING A MANUAL ESTIMATE ON ALL LABOR & DELIVERY SAMPLES WITH PLATELET VALUES LESS THAN 140,000 CELLS/UL. THE ESTIMATES ARE CONSIDERED CORRECT AND THESE ARE REPORTED OUT. THE SUPERVISOR OF THE LABOR AND DELIVERY DEPARTMENT PROVIDED EXAMPLES OF POSSIBLE CHANGES IN PATIENT TREATMENT ASSOCIATED WITH LOW PLT, BUT THE EXAMPLES WERE NOT SPECIFIC TO ANY OF THE PATIENT RESULTS SUBMITTED. SHE SAID THE CUT-OFF AND THE DECISION WOULD BE MADE BY EACH INDIVIDUAL ANESTHESIOLOGIST. THE COMPLAINANT DID NOT KEEP TRACK OF THE DIAGNOSIS AND TREATMENT. CONTROLS ARE RUN EVERY 8 HOURS ON THESE INSTRUMENTS AND A PATIENT CONTROL IS RUN EVERY 20 SAMPLES. CONTROLS RUN BEFORE AND AFTER THE INCIDENT RECOVERED WITHIN THE RANGES. THE TWO DXH INSTRUMENTS ARE CURRENTLY PERFORMING WITHIN THE PUBLISHED SPECIFICATIONS. RAW DATA HAS BEEN SUBMITTED TO BEC FOR ANALYSIS. THE RESULTS OF RAW DATA ANALYSIS ARE NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 1

    RAW DATA ANALYSIS WAS PERFORMED USING PROVIDED DATA FILES. IN MOST CASES, THE PLATELET HISTOGRAMS WERE FOUND TO HAVE CURVES WITH GOOD LOGNORMAL SHAPES WITH HIGH ENDS CLOSE TO THE BASELINE AND NO INDICATION OF UNDETECTED LARGE PLATELETS. IN CONCLUSION, THE REASON FOR THE DIFFERENCE BETWEEN THE DXH RESULTS AND THE MANUAL SLIDE ESTIMATES CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERRONEOUSLY LOW PLATELET RESULTS WERE GENERATED BY TWO UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS WITHOUT FLAGS OVER THE PERIOD BETWEEN (B)(6) 2011 AND (B)(6) 2012. MAJORITY OF THE ERRONEOUS RESULTS WERE HELD UNTIL THE MANUAL ESTIMATES WERE PERFORMED, BUT A FEW ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. FOR THESE, CORRECTED REPORTS WERE SENT OUT SHORTLY AFTER MANUAL ESTIMATES WERE PERFORMED. THE CUSTOMER WAS UNABLE TO ENUMERATE OR IDENTIFY THE SAMPLES REPORTED OUT. IMPACT TO THE PATIENT TREATMENT FOR THE REPORTED RESULTS IS UNKNOWN. THE INFORMATION WAS REQUESTED BUT HAS NOT BEEN SUPPLIED TO DATE. THIS REPORT DOCUMENTS THE EVENT OCCURRED ON (B)(6) 2011 ON ONE (1) PATIENT'S RESULTS GENERATED BY ONE OF THE TWO DXH 800 SYSTEMS. THE RELATED EVENTS ARE DOCUMENTED IN THE BELOW LISTED MDRS: 1061932-2012-00390, 1061932-2012-00392, 1061932-2012-00393, 1061932-2012-00394, 1061932-2012-00395, 1061932-2012-00396, 1061932-2012-00397, 1061932-2012-00398, 1061932-2012-00399, 1061932-2012-00400, 1061932-2012-00401, 1061932-2012-00402, 1061932-2012-00403, 1061932-2012-00404, 1061932-2012-00406.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR