BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF2 HEMATOLOGY ANALYZER

    MDR report key: 2080667 · Received May 6, 2011

    Report

    Report Number
    1061932-2011-00378
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED. QC BEFORE AND AFTER THE INCIDENT WAS WITHIN THE SPECIFICATIONS. SERVICE WAS ONSITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) REPLACED A MALFUNCTIONING LCD DISPLAY AND HARDWARE, BUT DID NOT FIND ANY ISSUES WITH PLT RECOVERY DURING HIS SERVICE VISIT. THE INSTRUMENT PERFORMANCE WAS VERIFIED AND VALIDATED. ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED RED BLOOD CELL (RBC) AND PLATELET (PLT) RESULTS GENERATED BY COULTER ACT DIFF2 HEMATOLOGY ANALYZER FOR ONE PATIENT SAMPLE. THE INSTRUMENT GENERATED FLAG FOR PLT ONLY. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS RERUN AND RECOVERED NORMAL RESULTS, WHICH WERE CONSIDERED CORRECT. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF2 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1