ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED
Received Dec 6, 2019 · Event occurred Nov 6, 2019
Report 1823260-2019-04298 · MDR key 9428994
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsModel number
ASTCatalog number
20764949322
Lot number
39767701
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2019, THE AST REAGENT CALIBRATION FAILED MULTIPLE TIMES. THE REAGENT PACK WAS EXCHANGED. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED AFTER THE REAGENT PACK WAS EXCHANGED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ASTL ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION ON A COBAS 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED WITH AN AST VALUE OF 21 U/L. THE SAMPLE WAS REPEATED, RESULTING AS 148 U/L. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2019, RESULTING WITH VALUES OF 34 U/L ACCOMPANIED BY A DATA FLAG AND 34 U/L. THE SECOND SAMPLE INITIALLY RESULTED WITH AN AST VALUE OF 131 U/L ON (B)(6) 2019. THE SAMPLE WAS REPEATED ON (B)(6) 2019, RESULTING WITH A VALUE OF 23 U/L. THE C 501 ANALYZER SERIAL NUMBER IS (B)(4).