ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED
Received Jul 26, 2019
Report 1823260-2019-90167 · MDR key 8830157
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsModel number
ASTLot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT THE ISSUE IS RELATED TO THE PATIENT SAMPLE AS THE PRESENCE OF MACRO AST WAS DETECTED IN THE SAMPLE AFTER PRECIPITATION WITH POLYETHYLENE GLYCOL (PEG). THERE WERE NO FOLLOW UP ACTIONS. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. DISCREPANT LOW RESULTS WERE GENERATED BY A COBAS 6000 C (501) MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: THREE SAMPLES WITH ERRONEOUS RESULTS FOR ASTL ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION.