¿-AMYLASE EPS VER.2

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE AMYLASE EPS VER.2 ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS 8000 CORE UNIT. THE INITIAL RESULT WAS -1 U/L (ACCOMPANIED BY A DATA FLAG). THE REPEAT RESULT WAS 199 U/L WITH A 5-FOLD DILUTION. THE SAMPLE WAS REPEATED NEAT AND THE RESULT WAS 0 (ACCOMPANIED BY A DATA FLAG), AND WITH A 1:5 DILUTION, THE RESULT WAS 198 U/L. NO ERRONEOUS RESULT WAS RELEASED OUTSIDE OF THE LABORATORY. AN INTERFERENCE IS SUSPECTED IN THE SAMPLE.

Additional Manufacturer Narrative

QC WAS ACCEPTABLE. PRE-ANALYTICAL HANDLING ANALYSIS SHOWED NO ABNORMALITIES. THE CUSTOMER HAS CONFIRMED THAT THIS ISSUE IS NOT RELATED TO THE INSTRUMENT, AS THE VERIFICATION RESULTS FOR THIS SAMPLE WERE CONSISTENT ON OTHER INSTRUMENTS. A REVIEW OF THE REACTION MONITOR ANALYSIS SHOWED THAT THE KINETICS OF THE UNDILUTED SAMPLE LOOK LIKE A CLEARING UP OF A TURBIDITY IN SOLUTION. DUE TO THE MULTIPLE MEDICATIONS INVOLVED, THE OBSERVED KINETICS LIKELY STEM FROM A COMBINATION OF UNKNOWN FACTORS, MAKING A DEFINITIVE ROOT CAUSE EXTREMELY DIFFICULT TO PINPOINT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.