BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENZ BENZODIAZEPINES PLUS

    MDR report key: 7078956 · Received December 4, 2017

    Report

    Report Number
    1823260-2017-02819
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    September 15, 2017
    Report Date
    December 27, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    PMA / PMN Number
    K043327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. TRENDING WAS PERFORMED ON THIS TYPE OF COMPLAINT AND NO ABNORMAL TREND WAS IDENTIFIED. DURING A REVIEW FOR THIS CUSTOMER SITE, THERE WERE NO SIMILAR PAST COMPLAINTS ON ANY LIKE INSTRUMENT FOR THE PAST 12 MONTHS.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED INFORMATION RELATED TO THE RELATIONSHIP BETWEEN BENZ BENZODIAZEPINES PLUS (BENZ) RUN ON A COBAS 6000 C (501) MODULE AND THE DRUG CLONAZEPAM. THE CUSTOMER IS A TOXICOLOGIST WHO IS GATHERING INFORMATION FOR A CRIMINAL CASE HE WILL BE TESTIFYING IN. THE CUSTOMER WANTED SENSITIVITY AND SPECIFICITY INFORMATION RELATED TO CLONAZEPAM AND THE BENZ TEST. THE CUSTOMER WAS INTERESTED IN THE CROSS-REACTIVITY BETWEEN CLONAZEPAM AND THE METABOLITE AGAINST WHICH BENZ IS MEASURED WHICH IS NORDIAZEPAM. THE CUSTOMER STATED 1 PATIENT URINE SAMPLE WAS TESTED FOR BENZ AND THE RESULT WAS "POSITIVE." THE ACTUAL RESULT WAS NOT PROVIDED. THE SAMPLE WAS REPEATED BY GAS CHROMATOGRAPHY¿MASS SPECTROMETRY (GC/ MS) METHOD AND THE RESULT WAS "NEGATIVE." THE ACTUAL RESULT WAS NOT PROVIDED. THE POSITIVE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED DUE TO THE RESULT FROM THE DEVICE. THE C501 MODULE SERIAL NUMBER WAS NOT PROVIDED. THE CUSTOMER WAS PROVIDED WITH CROSS-REACTIVITY INFORMATION FROM PRODUCT LABELING. PER PRODUCT LABELING THE BENZ ASSAY "PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GC/MS IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGEMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE USED." THE CROSS-REACTIVITY FOR CLONAZEPAM IS 68%. THE CUTOFF FOR BENZ IS 100 NG/ML. IT WOULD TAKE 148 NG/ML OF CLONAZEPAM TO CAUSE REACTIVITY COMPARABLE TO 100 MG/DL OF THE TARGET DRUG NORDIAZEPAM. AT THE 100 NG/ML CUTOFF, IT WOULD TAKE 148 NG/ML OF CLONAZEPAM (MORE THAN THE TARGET DRUG OF NORDIAZEPAM AT CUTOFF) TO CAUSE A POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858884 BENZ BENZODIAZEPINES PLUS ENZYME IMMUNOASSAY, BENZODIAZEPINE JXM ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1