BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT BENZODIAZEPINE

    MDR report key: 1023859 · Received April 1, 2008

    Report

    Report Number
    2018433-2008-00038
    Event Type
    Other
    Date Received
    April 1, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JXM
    PMA / PMN Number
    K013143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    AN ABBOTT REP STATED THAT A PT WAS ADMITTED TO THE ER IN 2008, FOR A SUSPECTED DRUG OVERDOSE. THE PT SAMPLE WAS TESTED FOR A COMPLETE DRUG SCREEN ( ALL TESTS NOT PROVIDED), WITH ALL RESULTS BEING NEGATIVE. THE NEXT DAY, A SECOND SAMPLE TESTED NEGATIVE. THE ER DOCTOR QUESTIONED THE BENZO RESULTS AND REQUESTED THE SAMPLE BE SENT OUT FOR CONFIRMATION. WHILE AWAITING THE TEST RESULT THE DOCTOR PROCEEDED WITH THE BENZO OVERDOSE TREATMENT. THE CONFIRMATORY TEST RESULTS FOR BOTH SAMPLES TESTED POSITIVE (3000 NG/ML) FOR LORAZEPAM. THE ABBOTT REP AT THE FACILITY RERAN THE SAMPLES ON MANY DILUTIONS AND ALL RESULTS WERE ARCHITECT BENZO NEGATIVE. THE SAMPLE IS BEING SENT OUT FOR ALTERNATE BENZO TESTING. THE ACCOUNT BELIEVES TO HAVE A FALSE NEGATIVE BENZO RESULT AND IS QUESTIONING IF THE ARCHITECT BENZO ASSAY IS DETECTING LORAZEPAM RATHER THAN BENZO. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT BENZODIAZEPINE QUANTITATIVE ANALYSIS OF BENZODIAZEPINE IN HUMAN URINE JXM ABBOTT MANUFACTURING, INC. NA 53041HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARCHITECT C8000 ANALYZER LIST # 1G06-01