BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENZODIAZEPINES

    MDR report key: 2260686 · Received September 22, 2011

    Report

    Report Number
    1823260-2011-05038
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 6, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. IT IS PROBABLE THAT THERE IS AN INTERFERING SUBSTANCE IN THE SAMPLE. THIS SUBSTANCE COULD NOT BE IDENTIFIED WITH AVAILABLE TEST METHODS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED TWO QUESTIONABLE BENZODIAZEPINES RESULTS ON THEIR INTEGRA 800 ANALYZER. PATIENT ONE RECEIVED A FALSE POSITIVE RESULT FOR BENZODIAZEPINE. PATIENT TWO RECEIVED A FALSE POSITIVE RESULT FOR BENZODIAZEPINE THE CUSTOMER CONFIRMED BOTH FALSE POSITIVE RESULTS USING OTHER IMMUNOCHEMICAL TEST METHODS LIKE EIA. THE SAMPLES WERE FURTHER TESTED BY GC/MS IN (B)(6) AND WERE FOUND TO BE NEGATIVE. IT IS UNKNOWN AT THIS TIME IF THE PATIENTS WERE ADVERSELY AFFECTED BY THIS EVENT. THE BENZODIAZEPINE REAGENT LOT NUMBER WAS 156314 AND THE EXPIRATION DATE WAS (B)(6) 2011. THE INITIAL INVESTIGATION SHOWS THERE IS POTENTIALLY AN UNKNOWN INTERFERING SUBSTANCE PRESENT IN THE SAMPLES. CLOZAPINE AND NEVIRAPINE, WHICH WERE DETECTED ON THE GC/MS DRUG SCREENING, SHOW NO CROSS- REACTIVITY WITH THE BENZODIAZEPINE ASSAY. FURTHER INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENZODIAZEPINES ENZYME IMMUNOASSAY, BENZODIAZIPINE JXM ROCHE DIAGNOSTICS NA 156314

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT 2 ESCITALOPRAM| PATIENT 2 RISPERIDON