BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TINA-QUANT C-REACTIVE PROTEIN IV

    MDR report key: 24965360 · Received April 23, 2026

    Report

    Report Number
    1823260-2026-01559
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 15, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DCN
    UDI-DI
    04015630946846
    PMA / PMN Number
    K192072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS 8000 C702 MODULE SERIAL NUMBER IS (B)(6). THE SERIAL NUMBERS FOR THE OTHER COBAS 8000 C702 AND THE COBAS C703 WERE NOT PROVIDED. IT WAS REPORTED THAT THE CUSTOMER SITE WAS UNDER TRANSITION FROM THE COBAS 8000 SYSTEMS TO THE COBAS PRO SYSTEMS. AS OF 23-MAR-2026, ALL COBAS C8000 INSTRUMENTS HAVE BEEN DEINSTALLED FROM THE SITE, AND THEY ARE NOW RUNNING ON COBAS PRO. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A SAMPLE-SPECIFIC ISSUE/INTERFERENCE. UPON FURTHER INVESTIGATION, AN IGM-TYPE M-COMPONENT RELATED TO THE PATIENT'S UNDERLYING CONDITION WAS IDENTIFIED, WHICH AFFECTED THE CRP RESULTS. PER PRODUCT LABELING, "IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH TINA-QUANT C-REACTIVE PROTEIN IV (CRP) RESULTS FROM TWO COBAS 8000 C702 MODULES AND A COBAS 703 MODULE FOR ONE PATIENT. ALLEGEDLY, A QUESTIONABLE HIGH CRP UP TO 500 MG/L CONTRIBUTED TO PROLONGED HOSPITALIZATION, ANTIBIOTIC TREATMENT, AND BRONCHOALVEOLAR LAVAGE. ON (B)(6) 2026, THE SAME SAMPLE WAS RUN ON 3 DIFFERENT ANALYSERS. ON COBAS C702 INSTRUMENT 2, THE RESULT WAS 449 MG/L, ACCOMPANIED BY A DATA FLAG. WITH DECREASED DILUTION, THE RESULT WAS 90 MG/L. THE SAMPLE WAS ADDITIONALLY MANUALLY DILUTED 1:2, WITH RESULTS OF 84 MG/L AND 1 MG/L. ON COBAS C702 INSTRUMENT 1, THE RESULT WAS 449 MG/L. WITH DECREASED DILUTION, THE RESULT WAS 91 MG/L. ON COBAS PRO C703, THE RESULT WAS 479 MG/L. WITH DECREASED DILUTION, THE RESULT WAS 109 MG/L. ON (B)(6) 2026 (COBAS C702 OR COBAS C703), THE RESULTS WERE 214 MG/L; 1:5 DILUTION: 20.4 MG/L; 1:10 DILUTION: 20 MG/L. ADDITIONALLY, THE PATIENT'S IGG WAS ANALYSED, AND THE RESULT WAS 3.44 G/L. ON (B)(6) 2026 (COBAS C702 OR COBAS C703), THE RESULTS WERE 100 MG/L; 1:5 DILUTION: 11 MG/L; 1:10 DILUTION: 13 MG/L. WITH A COMPETITOR SYSTEM, THE CRP AIDIAN QUICK READGO, THE RESULT WAS 106 MG/L. ON A SECOND COMPETITOR SYSTEM, THE CRP AFINION, THE RESULT WAS 10 MG/L. THE CAPILLARY ELECTROPHORESIS IGM KAPPA RESULT WAS 1.3 G/L. ON (B)(6) 2026 (COBAS C702 OR COBAS C703), THE RESULTS WERE 33.5 MG/L; 1:2 DILUTION:10.25 MG/L; 1:5 DILUTION: 9.5 MG/L; 1:10 DILUTION: 10 MG/L. ON THE COMPETITOR SYSTEM, THE CRP AIDIAN QUICK READGO, THE RESULT WAS 77 MG/L. ON A SECOND COMPETITOR SYSTEM, THE CRP AFINION, THE RESULT WAS 10 MG/L. REPORTEDLY, AN INTERFERENCE WAS SUSPECTED IN THE PATIENT SAMPLE, WHICH WAS RESOLVED AFTER DILUTION. REPORTEDLY, THE COMPETITOR SYSTEM RESULTS WERE CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. ON (B)(6) 2026, WITH THE COBAS PRO C703, THE RESULTS WERE 2.03 MG/L; 1:5 DILUTION: 1.11 MG/L; 1:10 DILUTION: 1.37 MG/L. THE PATIENT HAS REPORTEDLY BEEN DISCHARGED FROM THE HOSPITAL AND IS RECEIVING TREATMENT FOR THE UNDERLYING MEDICAL CONDITION (LYMPHOMA) IN PRIMARY CARE AS AN OUTPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460891 TINA-QUANT C-REACTIVE PROTEIN IV C REACTIVE PROTEIN TEST SYSTEM DCN ROCHE DIAGNOSTICS 906248 04015630946846

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other| H