BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONLINE DAT CANNABINOIDS II

    MDR report key: 24746631 · Received March 31, 2026

    Report

    Report Number
    1823260-2026-01181
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LDJ
    UDI-DI
    07613336121511
    PMA / PMN Number
    K030213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE CARRYOVER WAS SUSPECTED, AND CARRYOVER EXPERIMENTS WERE PERFORMED. ON (B)(6) 2026, A NEW RINSE STATION WAS INSTALLED. ON 24-MAR-2026, THE FIELD SERVICE ENGINEER (FSE) CHECKED THE SAMPLE PROBE, PROBE WASH, AND THE GEAR PUMP PRESSURE, AND ALL WERE ACCEPTABLE. THE FSE FOUND ISSUES WITH THE WATER AT THE CUVETTE SINK. THE TUBES WERE CLEANED, AND ADJUSTMENTS WERE MADE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED QUESTIONABLE POSITIVE RESULTS FOR AN ADDITIONAL PATIENT SAMPLE (PATIENT 3): THE INITIAL RESULT WAS 78.1 NG/ML. THE LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LC-MS) RESULT WAS NEGATIVE. ON 15-APR-2026, THE SAMPLE WAS REPEATED USING THE ROCHE METHOD, AND THE RESULT WAS 5.01 NG/ML. THE CUSTOMER IMPLEMENTED AUTOMATIC RE-RUN TESTING FOR ALL SAMPLES WITH ONLINE DAT CANNABINOIDS II VALUES BETWEEN 50 AND 100 NG/ML. THE CUSTOMER CONFIRMED THAT BOTH THE DISCREPANT AND THE CORRECT RESULTS WERE GENERATED USING THE SAME REAGENT KIT. THE CUSTOMER ALSO HAD CALIBRATION ISSUES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE POSITIVE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT URINE SAMPLES TESTED FOR ONLINE DAT CANNABINOIDS II (THC2) ON A COBAS C 503 ANALYTICAL UNIT. THE "POSITIVE" SAMPLES WERE CONFIRMED TO BE NEGATIVE USING LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LC-MS). EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES. ON (B)(6) 2026 PATIENT 1 RESULT FROM THE C503 ANALYZER WAS 50.3 NG/ML (CUTOFF OF 50 NG/ML). ON (B)(6) 2026, THE LC-MS RESULT WAS NEGATIVE. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON THE C503 ANALYZER WITH A RESULT OF 4.63 NG/ML. ON (B)(6) 2026 PATIENT 2 RESULT FROM THE C503 ANALYZER WAS 98.8 NG/ML (CUTOFF OF 50 NG/ML). ON (B)(6) 2026, THE LC-MS RESULT WAS NEGATIVE. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON THE C503 ANALYZER WITH A RESULT OF 8.40 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63425 ONLINE DAT CANNABINOIDS II ENZYME IMMUNOASSAY, CANNABINOIDS LDJ ROCHE DIAGNOSTICS 91046501 07613336121511

    Patients

    Seq Age Sex Outcome Treatment
    1