BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMMONIA II

    MDR report key: 23339359 · Received October 20, 2025

    Report

    Report Number
    1823260-2025-04263
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 18, 2025
    Report Date
    May 1, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIF
    UDI-DI
    04015630936533
    PMA / PMN Number
    K183517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AMMONIA II REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    AFTER THE INITIAL TEST, THE PATIENT WAS TESTED DAILY FOR 1 WEEK; A NEW SAMPLE WAS OBTAINED EACH DAY. THE RESULTS CONSISTENTLY SHOWED AMMONIA II RESULTS OF APPROXIMATELY [-] 1000 UG/DL ON VARIOUS UNSPECIFIED MODULES. TESTING WAS PERFORMED AT ANOTHER HOSPITAL USING A C702 MODULE WITH SIMILAR RESULTS. THE SPECIFIC RESULTS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT SAMPLE TESTED WITH AMMONIA II ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 1361 UG/DL (TESTED WITH NORMAL MODE AND ACCOMPANIED BY A DATA FLAG). THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT WAS A VERY LOW NEGATIVE RESULT AND REPEATED THE SAMPLE USING DIFFERENT DILUTION FACTORS IN A DECREASE MODE: 1ST REPEAT RESULT: 1700 UG/DL (USING A DILUTION FACTOR 1:2). 2ND REPEAT RESULT: 300 UG/DL (USING A DILUTION FACTOR 1:50). THE SAMPLE WAS THEN REPEATED ON A DIFFERENT C702 MODULE IN ANOTHER SITE AND THE 4TH REPEAT RESULT WAS -600 UG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14922 AMMONIA II ENZYMATIC METHOD, AMMONIA JIF ROCHE DIAGNOSTICS 869428 04015630936533

    Patients

    Seq Age Sex Outcome Treatment
    1