BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENZODIAZEPINES PLUS

    MDR report key: 4295848 · Received December 3, 2014

    Report

    Report Number
    1823260-2014-09566
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 21, 2014
    Report Date
    December 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    PMA / PMN Number
    K043327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE CUSTOMER REPORTED TO FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LORAZEPAM GLUCURONIDES REACT WITH THE REAGENT AT APPROXIMATELY 0.5% CROSS-REACTIVITY. THE REAGENT DOES NOT CONTAIN GLUCURONIDASE. IT WAS DETERMINED THE ASSAY WAS WORKING ACCORDING TO SPECIFICATION AND CROSS-REACTIVITY CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED INSTANCES WHERE A PATIENT WAS TAKING "LORAZEPINE" AND THE DOCTOR EXPECTED A POSITIVE RESULT FOR THE BENZODIAZEPINES PLUS ASSAY, BUT THE RESULT WAS NEGATIVE. TESTING BY MASS SPECTROMETER WAS POSITIVE FOR BENZODIAZEPINES. THE CUSTOMER STATED SHE KNEW OF "A COUPLE OF SAMPLES" THAT WERE EXPECTED TO BE POSITIVE DUE TO PATIENT MEDICATION, BUT WERE REPORTED AS NEGATIVE. FOLLOWING PHYSICIAN COMPLAINTS THE SAMPLES WERE TESTED BY MASS SPECTROMETRY AND WERE POSITIVE FOR BENZODIAZEPINES WITH RESULTS AS HIGH AS 12000 OR 15000 (NO UNITS OF MEASURE WERE PROVIDED). THE CUSTOMER COULD NOT PROVIDE THE ACTUAL DATES ON WHICH THESE EVENTS OCCURRED. NO PATIENTS WERE ADVERSELY AFFECTED. THE ANALYZER IN USE WAS A COBAS 8000 C 502 MODULE, SERIAL NUMBER (B)(4). THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND INDICATED THE CUSTOMER DID NOT BELIEVE THERE TO BE A PROBLEM WITH THE INSTRUMENT. THE FIELD SERVICE REPRESENTATIVE RAN A PRECISION STUDY WHICH WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781686 BENZODIAZEPINES PLUS ENZYME IMMUNOASSAY, BENZODIAZIPINE JXM ROCHE DIAGNOSTICS NA 69386501

    Patients

    Seq Age Sex Outcome Treatment
    1