ASPARTATE AMINOTRANSFERASE
Received Feb 27, 2026 · Event occurred Feb 11, 2026
Report 1823260-2026-00729 · MDR key 24471904
Device
Generic name
Aspartate Amino Transferase (ast/sgot) Test System
Manufacturer
Roche DiagnosticsCatalog number
05850819190
Lot number
912006
Product problems
- Output Problem
Patient
44 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELDS A2 AGE NUMBER, A2 AGE UNITS, AND B7 OTHER RELEVANT HISTORY WERE UPDATED. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE RESULTS FROM THE COBAS 8000 C702 MODULE. THE CUSTOMER SUSPECTED THERE WAS A PATIENT SPECIFIC ISSUE OR AN INTERFERENCE. THE INITIAL RESULT WAS 59.3 U/L WITH A DATA FLAG. THE REPEAT RESULT WAS 60.6 U/L WITH A DATA FLAG. A 1:10 DILUTION YIELDED A CALCULATED RESULT OF 44.8 U/L, SUGGESTING AN ANALYZER RESULT OF 4.8 U/L, WHICH IS BELOW THE ASSAY'S LOWER TECHNICAL LIMIT AND SHOULD NOT HAVE BEEN REPORTED BY THE ANALYZER. A 1:3 DILUTION YIELDED A CALCULATED RESULT OF 57.7 U/L.