BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 22787240 · Received August 12, 2025

    Report

    Report Number
    1823260-2025-02465
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 17, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREP2 REAGENT LOT NUMBER WAS 853138. THE EXPIRATION DATE WAS NOT PROVIDED. THE CRP4 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THAT THE RINSE WATER LEVEL FOR THE SAMPLE AND REAGENT PROBES WAS LOW, THE DETERGENT FILL LEVEL IN THE CUVETTES WAS LOW, AND THE GEAR PUMP PRESSURE WAS VERY HIGH. HE CLEANED THE SAMPLE AND REAGENT PROBES, CHECKED AND CLEANED THE RINSE TUBINGS AND NOZZLES, ADJUSTED THE FILL LEVELS OF DETERGENT IN THE CUVETTES, AND ADJUSTED THE RINSE WATER LEVELS AND THE GEAR PUMP PRESSURE. HE THEN PERFORMED AN INSTRUMENT CHECK, AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. QC WAS PERFORMED WITH SUCCESSFUL RESULTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. THE ROOT CAUSE WAS HARDWARE-RELATED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 (CREP2) AND 1 PATIENT SAMPLE TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV (CRP4) ASSAY ON A COBAS PURE C 303 ANALYTICAL UNIT. SAMPLE 1: CREP2: INITIAL RESULT: 80.9 UMOL/L. REPEAT RESULT: 64.3 UMOL/L. SAMPLE 2 WAS TESTED ON (B)(6) 2025 FOR CRP4: INITIAL RESULT: 2.96 UMOL/L (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 67.3 UMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350183 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown