BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2981761 · Received February 27, 2013

    Report

    Report Number
    2050012-2013-00117
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CARTRIDGE CHEMISTRY (CC). SAMPLE WASH COLLAR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUS CHOLESTEROL (CHOL), ALANINE AMINOTRANSFERASE (ALT) AND TRIGLYCERIDE (TG) RESULTS INVOLVING A UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER REPORTED THAT A 0 IU/L VALUE FOR ALT AND SUPPRESSED (NO NUMERICAL VALUE) RESULTS FOR TG WERE GENERATED BUT NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT THREE PATIENT SAMPLES WERE AFFECTED BUT PRINTOUTS FOR ONLY TWO PATIENT SAMPLES WERE PROVIDED. ERRONEOUSLY LOW CHOL RESULTS WERE REPORTED OUT OF THE LABORATORY BUT THERE WAS NO AFFECT OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE SAMPLES WERE REPEATED ON THE ORIGINAL AND/OR ALTERNATE DXC ANALYZER AND CORRECTED RESULTS WERE OBTAINED. QUALITY CONTROL (QC) RESULTS FOR ALL CARTRIDGE CHEMISTRIES (CC) PRIOR TO THE EVENT WERE WITHIN SPECIFICATIONS. PASSING CALIBRATION AND QC RESULTS FOR CHOLESTEROL WERE ALSO OBTAINED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) NOTED THAT THE CC SAMPLE SYRINGE WAS VERY STIFF AND DIFFICULT TO MOVE BY HAND. THE FSE PROCEEDED TO REPLACE THE CC SAMPLE SYRINGE, CC SAMPLE PROBE AND CC SAMPLE WASH COLLAR. REPAIRS WERE VERIFIED AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83654 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1