ASPARTATE AMINO TRANSFERASE
Received Apr 1, 2025 · Event occurred Mar 7, 2025
Report 1823260-2025-00968 · MDR key 21741562
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsCatalog number
08104719190
Lot number
833999
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINO TRANSFERASE RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.18 U/L. THE REPEAT RESULT WITH A 1:20 DILUTION WAS 3772 U/L WITH A DATA FLAG. THE NEXT DAY THE RESULT FROM A NEW SAMPLE HAD A HIGH RESULT ACCOMPANIED BY A DATA FLAG. NO SPECIFIC DATA WAS PROVIDED.
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE INVESTIGATION FOUND THE EVENT WAS CONSISTENT WITH A SAMPLE-SPECIFIC ISSUE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.