ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
Received Dec 8, 2025 · Event occurred Oct 21, 2025
Report 1823260-2025-04992 · MDR key 23744730
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
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE C 311 ANALYZER SERIAL NUMBER IS (B)(6). THE COBAS PURE ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 4000 C311 STAND ALONE SYSTEM AND A COBAS PURE ANALYZER. ON 21-OCT-2025, SAMPLE 1 HAD AN INITIAL ALT RESULT OF 52 IU/L FROM THE COBAS PURE ANALYZER. THE SAMPLE WAS ALSO TESTED ON A C 311 ANALYZER AND THE RESULT WAS 24 IU/L. THE EXACT DATE OF TESTING ON THE C 311 ANALYZER WAS NOT PROVIDED. SAMPLE 2 HAD AN INITIAL ALT RESULT OF 51.2 IU/L FROM THE COBAS PURE ANALYZER. THE SAMPLE WAS ALSO TESTED ON A C 311 ANALYZER AND THE RESULT WAS 21.8 IU/L. THE EXACT DATES OF TESTING WERE NOT PROVIDED.
Additional Manufacturer Narrative
NO FURTHER INFORMATION WAS PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.