BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLINE DAT BENZODIAZEPINES PLUS

    MDR report key: 3670532 · Received March 10, 2014

    Report

    Report Number
    1823260-2014-01673
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 21, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    PMA / PMN Number
    K043327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LORAZEPAM METABOLITES HAVE A 0.5% CROSS REACTIVITY WITH THE BENZ ASSAY. SINCE LORAZEPAM METABOLITES ARE FREQUENTLY PRESENT IN THE URINE, THE ASSAY WILL NOT DETECT IT WITH THE FOUND CONCENTRATION. THIS IS INDICATED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR BENZODIAZEPINES PLUS (BENZ) ON ONE PATIENT SAMPLE. THE INITIAL BENZ RESULT WAS NEGATIVE USING THE QUALITATIVE 200 NG/ML CUTOFF SCREENING TEST. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND WAS TESTED BY GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) AND GENERATED A RESULT OF 1557 NG/ML LORAZEPAM IN THE SAMPLE. THE CUSTOMER DEEMED THE GC/MS RESULT TO BE THE CORRECT RESULT. THERE WAS NO ADVERSE EVENT. THE LOT NUMBER FOR THE BENZ REAGENT IN USE WAS 68216501, WITH AN EXPIRATION DATE OF 01/31/2015. THE FIELD SERVICE REPRESENTATIVE FOUND THE GEAR PUMP PRESSURE WAS LOW. HE ADJUSTED THE PRESSURE TO SPECIFICATION. HE PERFORMED MECHANISM CHECKS, WHICH PASSED. THE CUSTOMER PERFORMED CALIBRATION AND QC SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143412 ONLINE DAT BENZODIAZEPINES PLUS ENZYME IMMUNOASSAY, BENZODIAZIPINE JXM ROCHE DIAGNOSTICS NA 68216501

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR ADAVAN