ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION
Received Jan 9, 2025 · Event occurred Dec 20, 2024
Report 1823260-2025-00072 · MDR key 21114953
Device
Generic name
Aspartate Amino Transferase (ast/sgot) Test System
Manufacturer
Roche DiagnosticsCatalog number
04467493190
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED ON THE LIMITED INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE INVESTIGATION CONCLUSION CODE WAS UPDATED.
Additional Manufacturer Narrative
THE C501 MODULE SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (AST) ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 46 U/L. THIS RESULT DID NOT CORRESPOND TO THE ALT RESULT (12 U/L) OR THE PATIENT¿S HISTORICAL RESULTS. THE REPEAT RESULT WAS 19 U/L. ON (B)(6) 2024 THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 19 U/L.