ASPARTATE AMINO TRANSFERASE
Received Nov 7, 2024 · Event occurred Oct 10, 2024
Report 1823260-2024-03219 · MDR key 20633453
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsCatalog number
08104719190
Lot number
809426
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
THE CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE ISSUE IS CONSISTENT WITH THE PATIENT'S CONDITION (RHABDOMYOLYSIS), WHICH CAN CAUSE AN INCREASE IN TRANSAMINASE WITHOUT AN INCREASE IN LIVER PARAMETERS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINO TRANSFERASE RESULTS FOR 1 PATIENT ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 923 U/L. THE PATIENT WAS SUSPECTED OF HAVING A NEUROMUSCULAR PATHOLOGY BUT WITHOUT THE ALTERATION OF THE OTHER RHABDOMYOLYSIS PARAMETERS. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 145 U/L. A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 967 U/L. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH A 1:10 DILUTION AND THE RESULT WAS 974 U/L. REPEAT TESTING WAS PERFORMED DUE TO THE INITIAL RESULTS NOT MATCHING THE PATIENT'S CLINICAL STATUS.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.