BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1334268 · Received March 5, 2009

    Report

    Report Number
    2050012-2009-00027
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 12, 2009
    Report Date
    March 5, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN OBSTRUCTION DETECTION ERRORS LATELY DUE TO THE CTA (CLOSED TUBE ACCESSING) PROBE HITTING THE GEL ON SEVERAL TUBES. FIELD SERVICE ENGINEER (FSE) VISITED AND FOUND THE CTA SAMPLE PROBE TUBING WAS LOOSE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY LOW PSA (PROSTATE SPECIFIC ANTIGEN) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. CUSTOMER TESTED TWO PATIENT SAMPLES FOR PSA AND OBTAINED RESULTS OF 0.04NG/ML (REPORTED AS 0.0NG/ML) AND 0.72NG/ML. THESE SAMPLES GAVE REPEAT RESULTS OF 0.44NG/ML AND 8.83NG/ML RESPECTIVELY. IT IS UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1