BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 6692692 · Received July 7, 2017

    Report

    Report Number
    1319808-2017-00011
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 4, 2017
    Report Date
    July 7, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A FALSE NEGATIVE VITROS BENZ RESULT (<85 NG/ML) WAS OBTAINED FROM A PATIENT SAMPLE BASED ON CONFIRMATORY TESTING USING A NON-VITROS METHOD, HDLC/MS AND CHEMILUMINESCENCE, WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE IS A KNOWN LIMITATION OF THE VITROS BENZ REAGENT RELATED TO LOW CROSS REACTIVITY WITH LORAZEPAM GLUCURONIDE. THERE IS NO EVIDENCE TO SUGGEST THAT THE VITROS BENZ REAGENT LOT 1523-30-5303 MALFUNCTIONED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED AN UNEXPECTED DISCORDANT VITROS BENZ NEGATIVE RESULT USING A <200 NG/ML CUTOFF FROM A URINE SAMPLE FROM A PATIENT SUSPECTED OF ACCIDENTALLY INGESTING LORAZEPAM WHEN THE PHYSICIAN EXPECTED A POSITIVE RESULT FROM THE PATIENT DUE TO THEIR CONDITION, ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 VITROS RESULT < 85 NG/ML (NEGATIVE) VERSUS AN EXPECTED POSITIVE RESULT (>200 NG/ML). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT VITROS BENZ RESULT WAS REPORTED OUT OF THE LABORATORY. HOWEVER, THERE WAS NO REPORT OF TREATMENT STARTED, STOPPED, OR ALTERED BASED ON THE FALSE NEGATIVE VITROS BENZ RESULT AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475553 VITROS CHEMISTRY PRODUCTS BENZ REAGENT IN-VITRO DIAGNOSTIC JXM ORTHO-CLINICAL DIAGNOSTICS 1523-30-5303

    Patients

    Seq Age Sex Outcome Treatment
    1