BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 973238 · Received December 28, 2007

    Report

    Report Number
    2050012-2007-00045
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Date of Event
    December 14, 2007
    Report Date
    December 28, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER NEGATIVE (-) METD RESULTS WERE QUESTIONED, CUSTOMER REVIEWED QC WHICH WAS UNACCEPTABLE. THEY THEN SHUT THE INSTRUMENT DOWN AND WAITED FOR SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND FOUND EVIDENCE OF LEAKING INSIDE THE REAGENT CAROUSEL. THE FSE COMPLETED REPAIR AND PERFORMED A PREVENTATIVE MAINTENANCE (PM) TO THE INSTRUMENT. AS PER PRODUCT LABELING, "THE METD ASSAY PROVIDES A RAPID SCREENING PROCEDURE FOR DETERMINING THE PRESENCE OF METHADONE IN URINE. THIS TEST PROVIDES ONLY A PRELIMINARY ANALYTICAL RESULT; A POSITIVE RESULT BY THIS ASSAY SHOULD BE CONFIRMED BY ANOTHER GENERALLY ACCEPTED NON-IMMUNOLOGICAL METHOD SUCH AS THIN LAYER CHROMATOGRAPHY (TLC), GAS CHROMATOGRAPHY (GC), OR GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS)". CUSTOMER AMENDED PT RESULTS TO POSITIVE WITHOUT BECKMAN COULTER INC. (BCI) RECOMMENDED GC/MS CONFIRMATORY TESTING. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE NEGATIVE (-) METHADONE (METD) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR MULTIPLE PT SAMPLES. THE CUSTOMER INDICATED THAT A PHYSICIAN QUESTIONED 5-6 URINE SAMPLES REPORTED AS NEGATIVE FOR METD. THE PHYSICIAN EXPECTED POSITIVE RESULTS BECAUSE ALL PTS WERE FROM A METD DRUG TREATMENT FACILITY. THE LAB RETESTED SAMPLES FOR METD AND OBTAINED POSITIVE (+) RESULTS. CUSTOMER AMENDED PT RESULTS TO (+). PT TREATMENT WAS NOT INITIATED OR WITHHELD BECAUSE PHYSICIAN QUESTIONED THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA