ASPARTATE AMINO TRANSFERASE
Received Apr 18, 2025 · Event occurred Mar 27, 2025
Report 1823260-2025-01180 · MDR key 21865197
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsCatalog number
08104719190
Lot number
833999
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). UPON REVIEW OF THE ANALYZER REACTION DATA, ANORMAL REACTIONS WERE OBSERVED FOR ALL MEASUREMENTS EXCEPT THE 3934 U/L MEASUREMENT. FLAGS INDICATING A REACTION ISSUE MEAN EITHER THE SAMPLE CONCENTRATION IS TOO HIGH, THE SAMPLE TURBIDITY IS TOO HIGH, OR THE REAGENT IS DETERIORATED. CALIBRATION DATA WAS ACCEPTABLE. MEDWATCH FIELD E1. INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING ALLEGED NON-REPRODUCIBLE ASTP2 ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 19.4 U/L. THE SAMPLE WAS REPEATED, BUT IT RESULTED IN NO VALUE, ONLY A FLAG INDICATING A REACTION ISSUE. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING IN AN AST VALUE OF 3934 U/L. THE SAMPLE WAS REPEATED TWO ADDITIONAL TIMES ON (B)(6) 2025, BUT EACH TIME IT DID NOT RESULT IN A VALUE, ONLY A FLAG INDICATING A REACTION ISSUE.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH A SAMPLE SPECIFIC ISSUE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.