BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC - T DIFF ANALYZER

    MDR report key: 1170273 · Received September 11, 2008

    Report

    Report Number
    1061932-2008-00048
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS DRAWN IN A 125UL SAFT-T-FILL FINGER STICK CAPILLARY COLLECTION DEVICE. QC IS RUN ONCE DAILY. QC WAS RUN BEFORE THE EVENT AND WAS WITHIN RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB. THE FSE INSPECTED THE INSTRUMENT AND DID NOT FIND ANY INSTRUMENT PROBLEMS. THE FSE REVIEWED SAMPLE COLLECTION AND MINIMUM FILL VOLUME REQUIREMENTS FOR THE FINGER STICK CAPILLARY COLLECTION DEVICES. THE FSE REPLACED THE DRAIN SOLENOID VALVE AS A PRECAUTION AND THE INSTRUMENT WAS VERIFIED AND VALIDATED PER ESTABLISHED PROCEDURES. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING ERRONEOUSLY LOW HEMOGLOBIN (HGB) AND PLATELET (PLT) RESULTS GENERATED BY THE COULTER AC - T DIFF ANALYZER FOR A SINGLE PT SAMPLE. HGB: INITIAL HGB RESULT WAS 6.9G/DL. THE RESULT WAS REPORTED OUT OF THE LAB AND THE PT WAS ADMITTED TO THE HOSPITAL, REDRAWN AND A HIGHER RESULT (8.6G/DL) WAS OBTAINED. THE HOSPITAL RESULT IS CONSIDERED CORRECT. THE CUSTOMER THEN RE-TESTED THE ORIGINAL SAMPLE FOR HGB WITH RESULT CORRELATING TO THE HOSPITAL'S RESULT (8.5G/DL). PLT: UPON DATA REVIEW, IT WAS NOTED THAT INITIAL PLT RESULT WAS LOW AS WELL, 143X10^3 CELLS/UL. THE HOSPITAL'S RESULT WAS 173X10^3 CELLS/UL. CUSTOMER RETESTED THE SAMPLE AND REPEATED PLT RESULT WAS 200X10^3 CELLS/UL. PER CONVERSATION WITH THE CUSTOMER, BASED ON THE HOSPITAL'S RESULT, THE PT DID RECEIVE A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC - T DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC - T DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA