BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BENZ REAGENT

    MDR report key: 20639756 · Received November 8, 2024

    Report

    Report Number
    1319808-2024-00040
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    August 22, 2024
    Report Date
    November 8, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JXM
    UDI-DI
    10758750001750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT FALSE NEGATIVE VITROS BENZODIAZEPINE (BENZ) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS PROCESSED USING VITROS CHEMISTRY PRODUCTS BENZ REAGENT LOT 1523-67-2046 IN COMBINATION WITH A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED FALSE NEGATIVE WHEN COMPARED TO RESULTS USING THE SAME SAMPLES FROM CONFIRMATORY TESTING USING GC/MS AND AN UNKNOWN REFERENCE METHOD. THE ASSIGNABLE CAUSE IS A KNOWN LIMITATION OF THE VITROS BENZ REAGENT RELATED TO LOW CROSS REACTIVITY WITH LORAZEPAM GLUCURONIDE. PER THE VITROS BENZ INSTRUCTION FOR USE (IFU) SPECIFICITY (CROSS REACTIVITY) TABLES, AT THE 200 NG/ML CUTOFF, VITROS BENZ REAGENT HAS A 34% CROSS REACTIVITY WITH LORAZEPAM. CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS BENZ REAGENT LOT 1523.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT FALSE NEGATIVE VITROS BENZODIAZEPINE (BENZ) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS PROCESSED USING VITROS CHEMISTRY PRODUCTS BENZ REAGENT LOT 1523-67-2046 IN COMBINATION WITH A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED TO BE FALSE NEGATIVES WHEN COMPARED TO RESULTS USING THE SAME SAMPLES FROM CONFIRMATORY TESTING USING GC/MS AND AN UNKNOWN REFERENCE METHOD. PATIENT 1 SAMPLE RESULT OF 143 NG/ML (NEGATIVE) VS AN EXPECTED RESULT OF POSITIVE PATIENT 2 SAMPLE RESULT OF 129 NG/ML (NEGATIVE) VS AN EXPECTED RESULT OF POSITIVE 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 RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS 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 (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905020 VITROS CHEMISTRY PRODUCTS BENZ REAGENT IN-VITRO DIAGNOSTICS JXM ORTHO-CLINICAL DIAGNOSTICS, INC. 1523-67-2046 10758750001750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown