BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5 DIFF CAP PIERCE (CP)

    MDR report key: 3942709 · Received July 17, 2014

    Report

    Report Number
    1061932-2014-01674
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED THE WBC (WHITE BLOOD CELL) RESULTS WERE FAILING REPRODUCIBILITY. THE WBC APERTURE AND COUNT SYRINGE O-RING WERE REPLACED RESOLVING THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RANDOM HIGH FLAGGED RESULTS FOR WBC (WHITE BLOOD CELL) COUNT AND BASOPHIL% (DIFFERENTIAL) ON MULTIPLE SAMPLES WHEN USING THE COULTER ACT 5 DIFF CAP PIERCE (CP). THE CUSTOMER INDICATED THAT ALL QUESTIONABLE RESULTS WERE RERUN ON THE SAME INSTRUMENT FOR VERIFICATION; RERUN RESULTS WERE REPORTED OUT AS CORRECT. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS REPORTED OUT OF THE LABORATORY FOR THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418200 COULTER ACT 5 DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1