BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750

    MDR report key: 902631 · Received August 23, 2007

    Report

    Report Number
    1061932-2007-00045
    Event Type
    Other
    Date Received
    August 23, 2007
    Date of Event
    July 27, 2007
    Report Date
    August 23, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC PERFORMED BEFORE AND AFTER THE EVENT RECOVERED WITHIN SPECIFICATIONS. THE SAMPLES WERE COLLECTED IN 3.5ML EDTA TUBES AND WERE CHECKED FOR CLOTS. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S LAB AND SERVICED THE INSTRUMENT. THE CUSTOMER STATED, THAT THEY BELIEVE THE EVENT TO BE PT RELATED AND NOT THE INSTRUMENT. AS PER PRODUCT LABELING, PLT CLUMPS ARE A KNOWN INTERFERING SUBSTANCE FOR THIS METHOD. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING THE COULTER LH 750 INSTRUMENT NOT FLAGGING PLATELET (PLT) CLUMPS AND HAD DECREASED PLT RESULTS ON TWO (2) PT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AND WERE QUESTIONED BY A PHYSICIAN. THE PHYSICIAN REQUESTED THAT SLIDES TO BE PERFORMED BASED ON THE PT'S HISTORY. CORRECTED REPORTS WERE SENT OUT. ACTUAL RESULTS WERE NOT PROVIDED. THERE WAS NO CHANGE TO PT TREATMENT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR