BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 12865332 · Received November 23, 2021

    Report

    Report Number
    1319808-2021-00023
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 23, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JXM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A FALSE NEGATIVE VITROS BENZ RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHEN COMPARED TO CONFIRMATORY TESTING ON THE SAME SAMPLE USING GC/MS. THE MOST LIKELY CAUSE IS A KNOWN LIMITATION OF THE VITROS BENZ REAGENT RELATED TO LOW CROSS REACTIVITY WITH LORAZEPAM GLUCURONIDE. LITERATURE SOURCES INDICATE THAT UNCHANGED LORAZEPAM IS EXCRETED IN NEGLIGIBLE AMOUNTS IN URINE. THE DRUG IS CONJUGATED ALMOST IMMEDIATELY AND BUILDS UP IN PLASMA AS THE CONJUGATED METABOLITE. THE LORAZEPAM CONJUGATED METABOLITE (LORAZEPAM GLUCURONIDE) IS THEN SLOWLY EXCRETED OVER TIME INTO THE URINE. AS STATED IN THE VITROS BENZ IFU, REFERENCE METHODS HYDROLYZE BENZODIAZEPINE GLUCURONIDES IN THE EXTRACTION PROCESS, INCREASING THE RECOVERY OF BENZODIAZEPINES BY THE REFERENCE METHOD AS COMPARED TO THE VITROS BENZ REAGENT. IT IS LIKELY THE URINE SAMPLE CONTAINED LORAZEPAM GLUCURONIDE AND THE REFERENCE METHOD USED HYDROLYZED THE LORAZEPAM GLUCURONIDE INCREASING THE LEVEL OF LORAZEPAM IN THE SAMPLE THAT WAS NOT AVAILABLE FOR THE VITROS BENZ REAGENT TO DETECT. AT THE 200 NG/ML CUTOFF, VITROS BENZ REAGENT HAS < 2.0% CROSS REACTIVITY WITH LORAZEPAM GLUCURONIDE, AND AT THE 300 NG/ML CUTOFF VITROS BENZ REAGENT HAS <3.0% CROSS REACTIVITY WITH LORAZEPAM GLUCURONIDE. LORAZEPAM GLUCURONIDE >10,000 NG/ML WOULD BE REQUIRED BEFORE THE VITROS BENZ REAGENT COULD DETECT IT SUGGESTING THIS COMPOUND IS VIRTUALLY UNDETECTABLE USING THE VITROS BENZ REAGENT. EMAIL ADDRESS FOR CONTACT OFFICE: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE VITROS BENZ RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHEN COMPARED TO CONFIRMATORY TESTING OF THE SAME PATIENT SAMPLE USING GC/MS. PATIENT RESULT OF <85 NG/ML VERSUS RESULT FROM GC/MS OF >2000 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE FALSE NEGATIVE VITROS BENZ RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764165 VITROS CHEMISTRY PRODUCTS BENZ REAGENT IN-VITRO DIAGNOSTICS JXM ORTHO-CLINICAL DIAGNOSTICS 1523-52-8562

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown