AMMONIA II
Received Mar 17, 2025 · Event occurred Feb 21, 2025
Report 1823260-2025-00749 · MDR key 21617667
Device
Generic name
Enzymatic Ammonia Method
Manufacturer
Roche DiagnosticsCatalog number
07229593190
Lot number
83242101
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA II RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 34.2 UMOL/L. THE RESULT FROM AN ABBOTT ALINITY I ANALYZER WAS 302.4 UMOL/L. THE CUSTOMER REPEATED THE SAME SAMPLE ON BOTH ANALYZERS. THE REPEAT RESULT FROM THE COBAS C502 WAS 54.4 UMOL/L. THE REPEAT RESULT FROM THE ABBOTT ALINITY I WAS 309.8 UMOL/L. THE RESULTS FROM THE ABBOTT ALINITY I ANALYZER WERE BELIEVED TO BETTER FIT THE PATIENT'S CLINICAL PICTURE.
Additional Manufacturer Narrative
THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE, AS THE VALUES ON THE COBAS C 502 WERE REPRODUCIBLE. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.