BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780

    MDR report key: 2264644 · Received September 26, 2011

    Report

    Report Number
    1061932-2011-01528
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A MICROTAINER TUBE, PROCESSED WITH ONE (1) HOUR IN THE SECONDARY (MANUAL MODE). OC IS RUN EVERY EIGHT HOURS. QC WAS RUN BEFORE AND TWO (2) HOURS AFTER THE EVENT. QC WAS PERFORMING WITHIN SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BASED ON RAW DATA, RET IN THE PROVIDED SAMPLE RESIDE IN THE WHITE BLOOD COUNT (WBC) SPACE. BASED ON COMPLETE BLOOD COUNT (CBC) INFORMATION, RET ARE MERGED WITH THE WBC EVENTS. BECAUSE OF THIS, THE RET EVENTS ARE MISCLASSIFIED. PER BEC LABELING: "BECKMAN COULTER INC., RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS. THERE MAY BE SITUATIONS WHERE THE PRESENCE OF RARE EVENTS MAY FAIL TO TRIGGER A SUSPECT MESSAGE. KNOWN INTERFERING SUBSTANCES FOR RETICULOCYTES: ERYTHROCYTE INCLUSIONS STAINED BY NEW METHYLENE BLUE, IF SUFFICIENTLY NUMEROUS WITHIN A SAMPLE, AND SOME HEMOGLOBINOPATHIES (SS, SC) MIGHT AFFECT THE ACCURACY OF THE RETICULOCYTE ENUMERATION". THE EVENT IS ASSOCIATED WITH THE FOLLOWING MDR: 1061932-2011-01531.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC), AND REPORTED THAT COULTER LH 780 ANALYZER GENERATED A FALSELY LOW RETICULATE (RET) RESULT FOR A SINGLE PATIENT. THE INSTRUMENT PRINTOUTS WERE NO LONGER AVAILABLE IN THE DATABASE (ONLY LAB INFORMATION SYSTEM (LIS) SCREEN SHOT). HOWEVER, PER RAW DATA FILES SUPPLIED, NO INSTRUMENT GENERATED RET FLAGS WERE PROVIDED. THE RESULT WAS BELIEVED TO BE ERRONEOUS BECAUSE THE RED BLOOD COUNT (RBC) MORPHOLOGY OBSERVED BY MANUAL SMEAR WAS NOT CONSISTENT WITH THE LOW RET VALUE. NO ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. THERE WAS NO DEATH, INJURY OR AN EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO