URIC ACID VER.2
Received May 4, 2026 · Event occurred Apr 14, 2026
Report 1823260-2026-01735 · MDR key 25073316
Device
Generic name
Uric Acid Test System
Manufacturer
Roche DiagnosticsModel number
5171857190Catalog number
05171857190
Lot number
91201001
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE QC WAS ACCEPTABLE. UPON REMOVING THE REAGENT AND INSPECTING ITS CONDITION, THE CUSTOMER FOUND THAT IT HAD TURNED DARK RED IN COLOR. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' SAMPLES TESTED WITH URIC ACID VER.2 ASSAY ON A COBAS 8000 C702 MODULE. SAMPLE 1: INITIAL RESULT: 702.2 MMOL/L. REPEAT RESULT: 244.4 MMOL/L. SAMPLE 2: INITIAL RESULT: 683.9 MMOL/L. REPEAT RESULT: 242.9 MMOL/L. SAMPLE 3: INITIAL RESULT: 692.6 MMOL/L. REPEAT RESULT: 298.8 MMOL/L. SAMPLE 4: INITIAL RESULT: 681.7 MMOL/L. REPEAT RESULT: 229.4 MMOL/L. SAMPLE 5: INITIAL RESULT: 675.9 MMOL/L. REPEAT RESULT: 439.4 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL DIAGNOSIS, AND REPEATED THE SAMPLES AFTER REPLACING THE REAGENT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULTS WITH THE LOWER VALUES WERE DEEMED TO BE CORRECT.