BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLINE DAT BENZODIAZEPINES PLUS

    MDR report key: 17374771 · Received July 21, 2023

    Report

    Report Number
    1823260-2023-02403
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 21, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    UDI-DI
    07613336170502
    PMA / PMN Number
    K043327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). IT WAS DETERMINED THAT THE TWO VERSIONS OF THE BENZ ASSAY ARE NOT DIRECTLY COMPARABLE. THE NEW VERSION OF THE ASSAY CONTAINS BETA-GLUCURONIDASE ENZYME WHILE THE OLD VERSION DOES NOT. TO BE COMPARED, THE SAMPLES WOULD NEED TO BE TREATED WITH BETA GLUCURONIDASE WHEN USING THE OLD VERSION. BOTH ASSAYS HAVE A DIFFERENT CROSS-REACTIVITY TO GLUCURONIDES. PER THE BENZ PRODUCT LABELING, "MANY BENZODIAZEPINES APPEAR IN THE URINE LARGELY AS THE GLUCURONIDATED CONJUGATE. GLUCURONIDATED METABOLITES MAY HAVE MORE OR LESS CROSS-REACTIVITY THAN THE PARENT COMPOUND." PER THE BNZ2 PRODUCT LABELING, "MANY BENZODIAZEPINES APPEAR IN THE URINE LARGELY AS THE GLUCURONIDATED CONJUGATE. GLUCURONIDATED METABOLITES MAY HAVE MORE OR LESS CROSS-REACTIVITY THAN THE PARENT COMPOUND. THE PRESENCE OF -GLUCURONIDASE ENZYME ENHANCES THE BENZODIAZEPINES II ASSAY CROSS-REACTIVITY TO SOME OF THE GLUCURONIDATED METABOLITES." NO PRODUCT PERFORMANCE ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE BENZ BENZODIAZEPINES PLUS URINE RESULTS FOR 4 PATIENT SAMPLES ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER STATED THAT THEY HAD BEEN PERFORMING A CORRELATION STUDY BETWEEN THE BENZ REAGENT AND THE NEW REAGENT VERSION. FOUR PATIENT SAMPLES GAVE A NEGATIVE BENZ RESULT AND A POSITIVE RESULT WITH THE NEW REAGENT VERSION. THE SAMPLES WERE SENT OUT FOR MASS SPECTROMETRY CONFIRMATION TESTING AND THE RESULTS WERE POSITIVE. THE CONFIRMATION RESULTS WERE DEEMED CORRECT. ONE OF THE PATIENTS' INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107034 ONLINE DAT BENZODIAZEPINES PLUS BENZODIAZEPINE ENZYME IMMUNOASSAY JXM ROCHE DIAGNOSTICS NA 63534601 07613336170502

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female AMBIEN| ATENOLOL| BUPROPION| DULOXETINE| GABAPENTIN| NORCO| NUCYNTA| PERCOCET| QUTENZA| XANAX