TINA-QUANT C-REACTIVE PROTEIN IV
Received Jun 29, 2026 · Event occurred Jun 9, 2026
Report 1823260-2026-02583 · MDR key 25651700
Device
Generic name
C Reactive Protein Test System
Manufacturer
Roche DiagnosticsCatalog number
07876424190
Lot number
926378
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ON A COBAS 8000 C702 MODULE. THE CUSTOMER NOTED THAT BOTH PATIENT AND QUALITY CONTROL RECOVERY HAVE INCREASED SIGNIFICANTLY. AFTER RE-CALIBRATION AND QUALITY CONTROL TESTING, THE REAGENT PERFORMS ACCEPTABLY. THREE EXAMPLES WERE PROVIDED OF PATIENT SAMPLES WITH DISCREPANT CRP RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 62.96 MG/L AND IT REPEATED AS 46.4 MG/L. THE SECOND SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 78.11 MG/L AND IT REPEATED AS 58.1 MG/L. THE THIRD SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 240.48 MG/L AND IT REPEATED AS 181.8 MG/L.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C702 ANALYZER IS (B)(6). THE FIELD SERVICE ENGINEER ADJUSTED SAMPLE PROBES, REAGENT PROBES, AND MIXERS. THE REAGENT PROBE WASH VOLUMES WERE CHECKED. THE INVESTIGATION IS ONGOING.