CREATININE JAFFE GEN.2
Received Jul 7, 2026 · Event occurred Jun 7, 2026
Report 1823260-2026-02717 · MDR key 25731514
Device
Generic name
Alkaline Picrate, Colorimetry, Creatinine
Manufacturer
Roche DiagnosticsCatalog number
06407137214
Lot number
ASKU
Product problems
- False Positive Result
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREATININE JAFFE GEN.2 RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. ON (B)(6) 2026, THE INITIAL RESULT WAS 187 UMOL/L. ON (B)(6) 2026, THE REPEAT RESULT WAS 80 UMOL/L.
Additional Manufacturer Narrative
THE COBAS 8000 C702 MODULE SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER INSPECTED THE MODULE, REPLACED THE SAMPLE AND REAGENT PROBES, FLUSHED THE RINSE TUBING, CLEANED THE ULTRASONIC MIXER AND WATER TANK, REPLACED THE CUVETTES, AND VERIFIED THE LEVEL.