BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON

    MDR report key: 99124 · Received June 6, 1997

    Report

    Report Number
    2050012-1997-00005
    Event Type
    Malfunction
    Date Received
    June 6, 1997
    Date of Event
    May 22, 1997
    Report Date
    June 6, 1997
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A REAGENT CARTRIDGE FOR PHE (PHENOBARBITAL) WAS AUTOLOADED BY BARCODE ON TO A SYNCHRON CX5 SYSTEM AS A PHY (PHENYTOIN) CARTRIDGE. CUSTOMER REPORTED THAT CALIBRATION WAS SUCCESSFUL AND CONTROLS WERE 'OK'. SEVERAL PT RESULTS WERE REPORTED. WHEN A RESULT WAS QUESTIONED, A SAMPLE WAS SENT TO A REFERENCE LAB FOR VERIFICATION. THE REFERENCE LAB VALUE WAS APPROX 1/2 OF THE ORIGINAL RESULT. PT RESULTS WERE REVIEWED AND SOME PT'S DOSAGES WERE DISCONTINUED OR DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CLINICAL CHEMISTRY ANALYZER - PHE REAGENT CARTRIDGE JJC BECKMAN INSTRUMENTS, INC. CXSP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other