BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRPHS

    MDR report key: 18173411 · Received November 20, 2023

    Report

    Report Number
    1823260-2023-03696
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    November 14, 2023
    Report Date
    November 20, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    UDI-DI
    04015630921508
    PMA / PMN Number
    K053603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER WAS 18M6-10. THE CUSTOMER DECLINED A SERVICE VISIT. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE BASED ON THE LIMITED INFORMATION. A SAMPLE-SPECIFIC ISSUE SUCH AS A POSSIBLE INTERFERING SUBSTANCE IN THE SAMPLE COULD NOT RULED OUT.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CRP LX HS RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 63.55 MG/L WITH A DATA FLAG. THE 1:15 AUTO-DILUTED RESULT WAS 10.8 MG/L. THE REPEAT RESULT WITH A 1:3 DILUTION WAS 65.89 MG/L WITH A DATA FLAG. THE 1:15 AUTO-DILUTED RESULT WAS 10.3 MG/L. THE RESULT USING A 1:5 DILUTION WAS 45.64 MG/L. THE RESULT USING A 1:10 DILUTION WAS 15.38 MG/L. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796399 CRPHS CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL NQD ROCHE DIAGNOSTICS 69280601 04015630921508

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown