BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS BENZODIAZEPINES

    MDR report key: 3664583 · Received March 6, 2014

    Report

    Report Number
    1823260-2014-01599
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 6, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    PMA / PMN Number
    K043327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 THE POSITIVE RESULTS FOR THREE OF THE PATIENT SAMPLES COULD BE FROM CROSS-REACTIVITY TO MEDICATION BEING GIVEN TO THE PATIENTS. THE MEDICATION CROSS REACTIVITY WITH THE ASSAY IS LISTED IN PRODUCT LABELING. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE POSITIVE RESULT FOR THE PATIENT WITH BIRTHDATE (B)(6). MOST PROBABLY, AN UNKNOWN SUBSTANCE IS CROSS-REACTING WITH THE ASSAY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER CLARIFYING THE DATA PREVIOUSLY REPORTED FROM ONE PATIENT WAS ACTUALLY FROM THREE SEPARATE PATIENTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR PATIENT DEMOGRAPHICS, MEDICATIONS AND DIAGNOSES.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED FALSE POSITIVE BENZODIAZEPINE RESULTS FOR SEVERAL PATIENT URINE SAMPLES. THE CUSTOMER DID NOT KNOW WHICH ANALYZER WAS USED FOR TESTING, BUT STATED COBAS C501 SERIAL NUMBER (B)(4) WAS NORMALLY USED FOR ALL DAT (DRUGS OF ABUSE) TESTING THE SPECIFIC NUMBER WAS SAMPLES AFFECTED WAS UNKNOWN. OF THE DATA PROVIDED FOR TWO PATIENTS, ONLY THE RESULTS FOR ONE PATIENT WERE DISCREPANT. THE PATIENT HAD THREE SEPARATE URINE SAMPLES COLLECTED FROM THE ER. SAMPLE 1 WAS TESTED ON (B)(6) 2014, SAMPLE 2 WAS TESTED ON (B)(6) 2014 AND SAMPLE 3 WAS TESTED ON (B)(6) 2014. ALL WERE REPORTED AS POSITIVE FOR BENZODIAZEPINE. ALL THREE SAMPLES WERE THEN FROZEN AND SENT FOR GC/MS ON (B)(6) 2014. THE RESULTS FOR ALL THREE SAMPLES WERE "NONE DETECTED" FOR BENZODIAZEPINE. THE POSITIVE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE GC/MS RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER DID NOT KNOW OF ANY AFFECTS TO ANY PATIENT. THE CUSTOMER REFUSED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135822 COBAS BENZODIAZEPINES ENZYME IMMUNOASSAY, BENZODIAZIPINE JXM ROCHE DIAGNOSTICS NA 68216501

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR (B)(4)