BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 2072359 · Received April 28, 2011

    Report

    Report Number
    1061932-2011-00324
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011324
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMEN WAS COLLECTED IN A 5 CC VACUTAINER TUBE AND SAMPLED <2 HOURS AFTER COLLECTION. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN ASSAY RANGES. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY AND PRECISION). SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE, BASED ON RAW DATA ANALYSIS, FOR THE ERRONEOUS DIFFERENTIAL RESULTS AND THE FALSE NEGATIVE BLAST FLAGGING IS THAT THE ALGORITHM COULD NOT SET SUSPECT FLAGS BECAUSE THERE ARE NO SIGNIFICANTLY ABNORMAL PATTERNS ON THE HISTOGRAMS. PER PRODUCT LABELING, BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 750 ANALYZER GAVE ERRONEOUS DIFFERENTIAL RESULTS ON A SPECIMEN WITHOUT INSTRUMENT GENERATED MESSAGES FROM ONE PATIENT. MANUAL REVIEW SHOWED ONE (1) BLAST. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1