ASTP
Received Jul 3, 2023 · Event occurred Jun 12, 2023
Report 1823260-2023-02160 · MDR key 17250596
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsModel number
NACatalog number
08056838190
Lot number
70098801
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). THE CUSTOMER NOTED THAT THE ASSAY USED WITH THE C503 ANALYZER USES PYRIDOXAL PHOSPHATE (PYP) ACTIVATION WHEREAS THE ASSAY USED WITH THE DXC 700 AU ANALYZER DOES NOT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (ASTP) ON A COBAS PRO C 503 ANALYTICAL UNIT COMPARED TO A DXC 700 AU ANALYZER. THE RESULT FROM THE C503 ANALYZER WAS 385 U/L. THE RESULT FROM A DXC 700 AU ANALYZER WAS 181.99 U/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
CALIBRATION AND QC WERE ACCEPTABLE, THEREFORE, A GENERAL REAGENT OR INSTRUMENT ISSUE IS NOT SUSPECTED. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH TWO DIFFERENT TESTS (ONE WITH PYRIDOXAL PHOSPHATE (PYP) ACTIVATION AND ONE WITHOUT PYP) BEING USED TO TEST THE PATIENT SAMPLE. ASSAYS WITH PYP SHOW HIGHER RESULTS COMPARED TO ASSAYS WITHOUT PYP. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.