CREATININE JAFF¿ GEN.2 (COMPENSATED)
Received Jun 22, 2026 · Event occurred May 18, 2026
Report 1823260-2026-02460 · MDR key 25576200
Device
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR THREE PATIENTS' SAMPLES TESTED WITH THE CREATININE JAFFE GEN.2 ASSAY ON A COBAS C 111 ANALYZER. SAMPLE 1: INITIAL RESULT: 0.77 MG/DL. REPEAT RESULT: 1.10 MG/DL. SAMPLE 2 WAS TESTED ON (B)(6) 2026: INITIAL RESULT: 0.61 MG/DL. REPEAT RESULT: 0.99 MG/DL. SAMPLE 3 WAS TESTED ON (B)(6) 2026: INITIAL RESULT: 0.65 MG/DL. REPEAT RESULT: 1.04 MG/DL. THE PATIENT SAMPLES WERE SENT OUT TO A DIFFERENT LABORATORY AND REPEATED ON A COBAS PRO C 503 ANALYTICAL UNIT.
Additional Manufacturer Narrative
THE COBAS C 111 ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.