BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENZ BENZODIAZEPINES PLUS

    MDR report key: 6921529 · Received October 6, 2017

    Report

    Report Number
    1823260-2017-02210
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    August 25, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    PMA / PMN Number
    K043327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE EVENT OCCURRED IN: (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS SUBMITTED FOR FURTHER INVESTIGATION TO CHECK FOR CROSS REACTIVITY OF BENZ WITH OLANZAPINE. THE RESULTS OBTAINED FROM THE SAMPLE WITH 100 ¿G/ML OF OLANZAPIN WERE BELOW THE LOWER DETECTION LIMIT OF THE ASSAY AND NO CROSS REACTIVITY OF THE OLANZAPIN COULD BE DETECTED. FURTHER INFORMATION WAS REQUESTED FROM THE CUSTOMER TO DETERMINE THE STATUS OF THE REAGENT AND INSTRUMENT ON THE DAY OF EVENT, BUT NO FURTHER INFORMATION WAS PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A FALSE POSITIVE BENZ BENZODIAZEPINES PLUS (BENZ) RESULT. THE INITIAL BENZ RESULT RUN ON A COBAS 8000 C 502 MODULE (C502) WAS POSITIVE (321 NG/ML). THE CLINICIAN QUESTIONED THE RESULT BECAUSE IF CONFIRMED THE PATIENT WOULD BE MOVED FROM A LOW SECURE TO A HIGH SECURE SETTING. THE REPEAT RESULT FROM THE SAME ANALYZER WAS AGAIN POSITIVE (328 NG/ML). REPEAT TESTING WAS PERFORMED ON (B)(6)2017. THE SAMPLE WAS SENT AWAY FOR CONFIRMATION TESTING USING GAS CHROMATOGRAPHY¿MASS SPECTROMETRY (GC/MS) AND A NEGATIVE RESULT WAS OBTAINED. THE NEGATIVE RESULT OBTAINED FROM THE GC/MS TESTING WAS BELIEVED TO BE CORRECT AS ALL PREVIOUS AND SUBSEQUENT RESULTS FOR THE PATIENT HAVE BEEN NEGATIVE FOR BENZ. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE C502 SERIAL NUMBER WAS (B)(4). SINCE THE PATIENT HAD TAKEN A DOSE OF OLANZAPINE PRIOR TO THE SAMPLE COLLECTION A POTENTIAL CROSS REACTIVITY WAS QUESTIONED BY THE CUSTOMER. A CROSS REACTIVITY OF BENZ WITH OLANZAPINE CAN BE EXCLUDED AS THE ROOT CAUSE. INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702286 BENZ BENZODIAZEPINES PLUS ENZYME IMMUNOASSAY, BENZODIAZEPINE JXM ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR