ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
Received May 30, 2025 · Event occurred Apr 30, 2025
Report 1823260-2025-01674 · MDR key 22116026
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Roche DiagnosticsCatalog number
20764957322
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
81 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GENERAL REAGENT ISSUE IS UNLIKELY BECAUSE QC AND CALIBRATION WERE IN RANGE AT THE TIME OF THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE AN EXACT ROOT CAUSE, AND NO PRODUCT ISSUE WAS FOUND.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION RESULT FROM THE COBAS 6000 C501 MODULE, SUSPECTING A NEGATIVE INTERFERENCE. THE INITIAL RESULT WAS 67.3 U/L, ACCOMPANIED BY A DATA FLAG, WITH A REPEAT RESULT OF 97.6 U/L, ALSO ACCOMPANIED BY A DATA FLAG. AFTER THE SAMPLE WAS DILUTED, THE DATA FLAG DID NOT OCCUR, HOWEVER, THIS RESULT WAS NOT REPRODUCIBLE ON REPEAT TESTING ON DIFFERENT ANALYZERS.
Additional Manufacturer Narrative
THE COBAS 6000 C501 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.