BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENZODIAZEPINES

    MDR report key: 3406079 · Received October 11, 2013

    Report

    Report Number
    1823260-2013-06252
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    September 13, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NFV
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS THE SAMPLE WAS NOT AVAILABLE FOR FURTHER TESTING. THE SAMPLE SHOWED A HIGH TITER OF COTININE. COTININE IS AN INDICATOR FOR SMOKER ESPECIALLY A HIGH COTININE AND THIOCYANATE CONCENTRATION IN THE SAMPLE. SMOKERS ARE BUILDING SO-CALLED SS-CARBOLINES, LIKE HARMANE AND NORHARMANE, WHICH ARE STRUCTURAL VERY SIMILAR TO BENZODIAZEPINES AND CAN BIND TO THE BENZODIAZEPINE RECEPTORS AS ENDOGENOUS INHIBITORS. DUE TO THE STRUCTURAL SIMILARITY THESE SUBSTANCES COULD ALSO BIND TO THE ANTI- BENZODIAZEPINE ANTIBODY IN THE ASSAY.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAVE AN ONGOING ISSUE WITH QUESTIONABLE BENZODIAZEPINE RESULTS FOR ONE OR TWO URINE SAMPLES PER DAY. DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE WHERE THE RESULT WAS POSITIVE BUT THEN CONFIRMED NEGATIVE BY GC-MS. THE INITIAL RESULT WAS >2000 NG/ML WITH A DATA FLAG. ON (B)(6) 2013, THE RESULT BY GC-MS WAS NEGATIVE. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LAB. THERE WERE NO ADVERSE EVENTS REPORTED. THE BENZODIAZEPINE REAGENT LOT NUMBER WAS 680717 WITH AN EXPIRATION DATE OF 08/31/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521378 BENZODIAZEPINES ENZYME IMMUNOASSAY, BENZODIAZIPINE NFV ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR