BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 3453500 · Received November 6, 2013

    Report

    Report Number
    1319808-2013-00046
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    September 18, 2013
    Report Date
    November 6, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED NEGATIVE VITROS BENZ RESULTS WERE OBTAINED FROM TWO PATIENT SAMPLES RUN ON THE VITROS 5600 INTEGRATED SYSTEM. TWO DIFFERENT VITROS BENZ REAGENT LOTS WERE AFFECTED BY THIS ISSUE. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT MALFUNCTION OCCURRED. THE INTENDED USE SECTION OF THE VITROS BENZ IFU STATES THAT THE VITROS CHEMISTRY PRODUCTS BENZ ASSAY IS INTENDED FOR USE BY PROFESSIONAL LABORATORY PERSONNEL. IT PROVIDES ONLY A PRELIMINARY TEST RESULT. A MORE SPECIFIC ALTERNATIVE CHEMICAL METHOD MUST BE USED TO CONFIRM A RESULT OBTAINED WITH THIS ASSAY. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG-OF-ABUSE TEST RESULT THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. A VITROS BENZ REAGENT ISSUE OR SAMPLE MIX-UP CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. HOWEVER, THERE IS NO SPECIFIC EVIDENCE TO SUGGEST THAT SAMPLE MIX-UP OCCURRED BEYOND THE UNEXPECTED RESULTS THEMSELVES. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED UNEXPECTED NEGATIVE VITROS BENZ RESULTS (< 200 NG/ML CUTOFF VALUE) FROM TWO PATIENT SAMPLES RUN ON THE VITROS 5600 INTEGRATED SYSTEM. THE NEGATIVE VITROS BENZ RESULTS WERE CONSIDERED TO BE UNEXPECTED BASED ON POSITIVE BENZ RESULTS OBTAINED USING AN ALTERNATE URINE DRUG SCREENING DEVICE AND AT A REFERENCE LABORATORY (BENZ COMPOUNDS DETECTED > 800 NG/ML). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE UNEXPECTED NEGATIVE VITROS BENZ RESULTS WERE INITIALLY REPORTED OUT OF THE LABORATORY. HOWEVER, THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573451 VITROS CHEMISTRY PRODUCTS BENZ REAGENT IN-VITRO DIAGNOSTIC JXM ORTHO-CLINICAL DIAGNOSTICS 1523-15-2985

    Patients

    Seq Age Sex Outcome Treatment
    1