ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
Received Jun 16, 2015 · Event occurred Apr 6, 2015
Report 1823260-2015-03640 · MDR key 4846629
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsModel number
NACatalog number
20764949322
Lot number
61168
Product problems
- Incorrect Or Inadequate Test Results
Patient
025 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE ASPARTATE AMINOTRANSFERASE (AST) RESULTS FOR ONE PATIENT FROM A COBAS C501. (B)(6) 2015: 311 U/L 02/21/2015: 551 U/L 10/09/2013: 291 U/L IT WAS UNCERTAIN IF THESE RESULTS WERE GENERATED FROM THE SAME PATIENT SAMPLE. WITH THE SAMPLE THAT GENERATED THE RESULT OF 311 U/L, THE CUSTOMER PERFORMED PRECIPITATION WITH PEG5000: SAMPLE WITH PEG5000 25% IN PBS (1)- <10 U/L SAMPLE WITH PEG5000 25% IN PBS (2)- <10 U/L %PPA 96.8% (PPA REF 18-53 %). THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER SUSPECTED THE PRESENCE OF A MACROENZYME, ONE COMPLEXED WITH AN IMMUNOGLOBULIN AND AST.
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE PROVIDED DATA, IT WAS DETERMINED THE TEST MEASURED THE CORRECT AMOUNT OF AST IN THE PATIENT SAMPLE WHICH WAS ELEVATED DUE TO POSSIBLE MACRO ENZYMES.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).