BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENZ BENZODIAZEPINES

    MDR report key: 6188420 · Received December 20, 2016

    Report

    Report Number
    1823260-2016-02018
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 5, 2016
    Report Date
    January 13, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. AS THE SAMPLE IN QUESTION WAS NOT AVAILABLE, FURTHER INVESTIGATION WAS NOT POSSIBLE. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. IT WAS SUSPECTED A SUBSTANCE IN THE SAMPLE WAS INTERFERING WITH THE ASSAY. CALIBRATION AND QC DATA WERE ACCEPTABLE AND DID NOT INDICATE ANY REAGENT ISSUE AND CONFIRMED THE ASSAY WAS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE BENZ BENZODIAZEPINES RESULTS FOR ONE PATIENT FROM COBAS INTEGRA 400 PLUS SERIAL NUMBER (B)(4). THE URINE RESULT WAS NEGATIVE AND WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER USED A VALUE OF 200 FOR THE CUTOFF POINT FOR THE ASSAY. AS THE PATIENT WAS ON LORAZEPAM AND THE RESULT WAS EXPECTED TO BE POSITIVE, THE PHYSICIAN ASKED FOR CONFIRMATION TESTING. THE CUSTOMER SENT THE SAMPLE FOR CONFIRMATION TESTING BY GC/MS AND THE RESULT WAS 1074 NG/ML (POSITIVE). THE RESULT BY GC/MS WAS BELIEVED TO BE CORRECT. ON (B)(6) 2016, THE CUSTOMER REPEATED THE SAME SAMPLE ON THE COBAS INTEGRA 400 PLUS AND THE RESULT WAS AGAIN NEGATIVE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER REFUSED A SERVICE VISIT TO CHECK THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839412 BENZ BENZODIAZEPINES ENZYME IMMUNOASSAY, BENZODIAZEPINE JXM ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 LORAZEPAM