BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLINE DAT BENZODIAZEPINES II

    MDR report key: 22493339 · Received July 14, 2025

    Report

    Report Number
    1823260-2025-02131
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 4, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JXM
    UDI-DI
    07613336121054
    PMA / PMN Number
    K221765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE FIRST C 503 ANALYZER IS (B)(6) AND THE SERIAL NUMBER OF THE SECOND C 503 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    NO PATIENT SAMPLES WERE AVAILABLE FOR INVESTIGATION. A PENECILLIN G INTERFERENCE IS UNLIKELY AS 100 UG/ML WITH 75 NG/ML NORDIAZEPAM SHOWED NO INTERFERENCE. INTERFERENCE WITH OXYTOCIN WAS TESTED AT 100 G/ML AND IN THE PRESENCE OF 75 NG/ML NORDIAZEPAM. BOTH APPROACHES WERE COMPLETELY INCONSPICUOUS. TYPICAL INJECTABLE SOLUTIONS ARE PREPARED WITH APPROXIMATELY 20 G/ML LEADING TO 20 G/ML CONCENTRATIONS IN THE CIRCULATION AND CONSEQUENTLY IN THE URINE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED FALSE POSITIVE RESULTS FOR THREE PATIENT SAMPLES TESTED WITH ONLINE DAT BENZODIAZEPINES II ON TWO COBAS C 503 ANALYTICAL UNIT ANALYZERS. THE FIRST PATIENT'S SAMPLE RESULTED IN A BENZODIAZEPINES VALUE OF 76.5 MABS (POSITIVE) WHEN TESTED ON THE FIRST C 503 ANALYZER AND IT RESULTED IN A VALUE OF 59.5 MABS (POSITIVE) WHEN TESTED ON THE SECOND C 503 ANALYZER. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR GC/MS CONFIRMATION TESTING AND THE RESULT WAS NEGATIVE (SEE ATTACHMENT FOR FULL RESULTS). THE SECOND PATIENT'S SAMPLE RESULTED IN A BENZODIAZEPINES VALUE OF 12.5 MABS (POSITIVE) WHEN TESTED ON THE FIRST C 503 ANALYZER ON (B)(6) 2025 AND IT RESULTED IN A POSITIVE WHEN TESTED ON THE SECOND C 503 ANALYZER ON (B)(6) 2025. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR GC/MS CONFIRMATION TESTING AND THE RESULT WAS NEGATIVE (SEE ATTACHMENT FOR FULL RESULTS). THE THIRD PATIENT'S SAMPLE RESULTED IN A BENZODIAZEPINES VALUE OF 10.8 MABS (POSITIVE) WHEN TESTED ON THE FIRST C 503 ANALYZER ON (B)(6) 2025 AND IT RESULTED IN A VALUE OF 20.9 MABS (POSITIVE) WHEN TESTED ON THE SECOND C 503 ANALYZER ON (B)(6) 2025. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR GC/MS CONFIRMATION TESTING AND THE RESULT WAS NEGATIVE (SEE ATTACHMENT FOR FULL RESULTS). THE NEGATIVE GC/MS RESULTS FOR ALL THREE PATIENTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728649 ONLINE DAT BENZODIAZEPINES II BENZODIAZEPINE GROUP IVD, KIT, ENZYME IMMUNOASSAY (EIA) JXM ROCHE DIAGNOSTICS 80283701 07613336121054

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female REFER TO THE ATTACHMENT FOR ALL PATIENT MEDICATION