MalfunctionJIF
AMMONIA
Received Jun 22, 2026 · Event occurred May 29, 2026
Report 1823260-2026-02467 · MDR key 25584829
Device
Generic name
Enzymatic Method, Ammonia
Manufacturer
Roche DiagnosticsCatalog number
20766682322
Lot number
925432
Product problems
- Incorrect Measurement
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 1.9 MMOL/L, AND THE REPEATED RESULT WAS 38.3 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT WAS NOT CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.