BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE

    MDR report key: 22674630 · Received July 31, 2025

    Report

    Report Number
    1823260-2025-02359
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 31, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    UDI-DI
    07613336121207
    PMA / PMN Number
    K053603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE CUSTOMER NOTED THAT THE SAMPLE GAVE HIGH IGM RESULTS OF 37.5 MG/L. THE CUSTOMER SUSPECTS INTERFERENCE DUE TO THIS INFORMATION. A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION; THEREFORE, IT WAS NOT POSSIBLE TO DEFINE THE ROOT CAUSE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 76 MG/L, ACCOMPANIED BY A DATA FLAG. WHEN RUN ON DECREASED SAMPLE VOLUME MODE, AND THE RESULT WAS 0.000 MG/L, ACCOMPANIED BY A DATA FLAG. MANUAL DILUTIONS OF 1:5, 1:10, AND 1:20 WERE COMPLETED, AND THE RESULTS WERE 0.000 MG/L, ACCOMPANIED BY A DATA FLAG. THEY TRIED TO WARM THE SAMPLE AND STILL RECEIVED A RESULT OF 76 MG/L, ACCOMPANIED BY A DATA FLAG. THEY RAN THE SAMPLE ON CRP4 AND RECEIVED A RESULT OF 8.68 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34892 CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL NQD ROCHE DIAGNOSTICS 782382 07613336121207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown