BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMMONIA II

    MDR report key: 22802463 · Received August 14, 2025

    Report

    Report Number
    1823260-2025-02479
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 22, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    UDI-DI
    04015630936526
    PMA / PMN Number
    K183517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QC RESULTS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER DID NOT FIND ANY ISSUES. HE CHECKED THE PUMP PRESSURES, ADJUSTED ALL PROBES AND RINSE LEVELS, AND CHECKED THE OUTPUT OF PROBE WASHES AND SAMPLE CLEANER. HE RAN PRECISION TESTING TO VERIFY THE OPERATION OF THE ANALYZER, WHICH WAS ACCEPTABLE. DUE TO THE INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE COBAS 6000 C 501 SERIAL NUMBER WAS (B)(6). THE CUSTOMER REPLACED THE REAGENT PACK, RECALIBRATED THE ASSAY, AND RAN QC. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA II RESULTS FROM THE COBAS 6000 C 501 ANALYZER FOR A TOTAL OF SEVEN SAMPLES FROM THREE PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER. FIVE EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT WAS 318.6 UG/DL, AND THE REPEAT RESULTS WERE 28.3 UG/DL AND 28.5 UG/DL. SAMPLE 2 INITIAL RESULT WAS 332.6 UG/DL, AND THE REPEAT RESULT WAS 23.8 UG/DL. SAMPLE 3 INITIAL RESULT WAS 165.1 UG/DL, AND THE REPEAT RESULT WAS 75.8 UG/DL. SAMPLE 4 INITIAL RESULT WAS 212.3 UG/DL, AND THE REPEAT RESULT WAS 31.9 UG/DL. SAMPLE 5 INITIAL RESULT WAS 472.5 UG/DL. THE REPEAT RESULT WITH A 1:2 DILUTION WAS 486.0 UG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 44.6 UG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956220 AMMONIA II ENZYMATIC AMMONIA METHOD JIF ROCHE DIAGNOSTICS 83242101 04015630936526

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female PATIENT 1: ELIQUIS