COBAS 6000 C501 MODULE

Additional Manufacturer Narrative

DUE TO INSUFFICIENT DATA PROVIDED FOR THE INVESTIGATION, THE ROOT CAUSE OF THE DISCREPANCIES COULD NOT BE DETERMINED. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED PRESENTLY, THE INSTRUMENT IS WORKING AS EXPECTED.

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE ASPARTATE AMINOTRANSFERASE (AST), ALANINE AMINOTRANSFERASE (ALT) AND CREATINE KINASE (CK) RESULTS FOR ONE PATIENT. THE CUSTOMER PROVIDED RESULTS FOR TWO SAMPLES FROM THE PATIENT. THE RESULTS FROM ONE SAMPLE WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL AST RESULT WAS -5 U/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS RETESTED ON THIS COBAS 6000 C501 ANALYZER AND GENERATED A RESULT OF -5 U/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS DILUTED AND RETESTED ON ANOTHER COBAS 6000 C501 ANALYZER (SERIAL NUMBER (B)(4)) AND GENERATED A RESULT OF -1 U/L (ACCOMPANIED BY A DATA FLAG). THE DILUTED SAMPLE WAS REPEATED AGAIN AND GENERATED AN AST RESULT OF 6456 U/L. THE CUSTOMER DID NOT KNOW WHICH ANALYZER THIS RESULT WAS GENERATED FROM. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE CORRECTED RESULT. THE INITIAL ALT RESULT WAS 197 U/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS RETESTED ON THIS COBAS 6000 C501 ANALYZER AND GENERATED A RESULT OF 425 U/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS DILUTED AND RETESTED AGAIN AND GENERATED A RESULT OF 4778 U/L (ACCOMPANIED BY A DATA FLAG). THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE CORRECTED RESULT. THE INITIAL CK RESULT WAS 43858 U/L. THIS RESULT WAS REPORTED AND NEVER CORRECTED. THE SAMPLE WAS RETESTED ON THIS COBAS 6000 C501 ANALYZER AND GENERATED A RESULT OF 74 U/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS DILUTED AND RETESTED ON THE OTHER COBAS 6000 C501 ANALYZER (SERIAL NUMBER (B)(4)) AND GENERATED A RESULT OF 208 U/L (ACCOMPANIED BY A DATA FLAG). THERE WAS NO ADVERSE AFFECT TO THE PATIENT FROM THE DISCREPANT RESULTS BEING REPORTED. THE AST REAGENT LOT NUMBER WAS 63417801. THE ALT REAGENT LOT NUMBER WAS 63590501. THE CK REAGENT LOT NUMBER WAS 63546001. THE FIELD SERVICE REPRESENTATIVE DID NOT FIND THE CAUSE OF THE DISCREPANCIES. HE RAN PERFORMANCE TESTS WHICH WERE WITHIN SPECIFICATION. THE OPERATOR PERFORMED QUALITY CONTROL AND PRECISION TESTS, ALL WERE ACCEPTABLE.