BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 1776827 · Received July 30, 2010

    Report

    Report Number
    1061932-2010-00096
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN 3ML VACUTAINER EDTA, STORED AT ROOM TEMPERATURE AND PROCESSED WITHIN 1 HOUR OF COLLECTION. CONTROLS ARE RUN ONCE PER DAY AND WERE WITHIN ASSAY LIMITS PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA WAS ANALYZED AND SHOWED 16% BLAST ACCORDING TO MANUAL REFERENCE. ROOT CAUSE FOR THIS EVENT IS THE ABNORMALITY OF THE PATTERN IS NOT SIGNIFICANT FOR THE ALGORITHM TO SET A BLAST FLAG.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT THE COULTER® LH 750 ANALYZER FAILED TO PROVIDE INSTRUMENT DIFFERENTIAL FLAGS ON A SAMPLE THAT WAS FOUND TO HAVE BLASTS BY MANUAL REVIEW. THE MANUAL DIFFERENTIAL INDICATED 16% MYELOBLASTS WHICH THE LAB CONSIDERED THE CORRECT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. NO DEATH OR INJURY BEEN REPORTED AND PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1