COBAS AMPLIPREP / COBAS TAQMAN HCV TEST

Description of Event or Problem

A CUSTOMER SITE RELEASED TEST RESULTS FROM AN INVALID COBAS AMPLIPREP / COBAS TAQMAN HCV TEST TEST RUN; INVALID HCV (B)(6) CONTROL. THE CUSTOMER REPORTED THAT THEY RUN AN EXTERNAL (B)(6) CONTROL THAT WAS WITHIN RANGE, AND THEREFORE, THE CUSTOMER SITE DETERMINED THAT IT WAS ACCEPTABLE TO RELEASE THE TEST RESULTS FROM THE INVALID TEST RUN. THE INVALID TEST RUN CONTAINED NINE PATIENT SAMPLES. THE CUSTOMER SITE INDICATED THAT THEY ARE NOT AWARE OF ANY ADVERSE PATIENT IMPACT DUE TO THE RELEASE OF THE INVALID TEST RESULTS.

Additional Manufacturer Narrative

AS PER THE PRODUCT LABELING, CUSTOMERS ARE INSTRUCTED THAT OF THE COBAS TAQMAN NEGATIVE CONTROL, THE HCV LOW POSITIVE CONTROL AND THE HCV HIGH POSITIVE CONTROL MUST BE INCLUDED IN EACH TEST RUN. IF ANY CONTROL IS INVALID, THE CUSTOMER MUST REPEAT THE ENTIRE PROCESS (SPECIMEN AND CONTROL PREPARATION, AMPLIFICATION AND DETECTION). AS REPORTED BY THE CUSTOMER, PATIENT RESULTS THAT WERE GENERATED WITHIN A TEST RUN THAT CONTAINED AN INVALID HCV (B)(6) CONTROL WERE RELEASED. THIS IS AN OFF-LABEL PRACTICE THAT MIGHT RESULT IN THE RELEASE OF ERRONEOUS, BUT BELIEVABLE, RESULTS. IN ADDITION TO THE LABELING WITHIN THE PACKAGE INSERT, A PRODUCT BULLETIN (NO. 2009/013) WAS MADE AVAILABLE IN OCTOBER 2009 TO REAFFIRM THAT TEST RESULTS MUST NOT BE REPORTED IF THE TEST RUN IS INVALID. THIS ISSUE DOES NOT REPRESENT A PRODUCT MALFUNCTION AS THE PRODUCT LABELING PROVIDES CLEAR AND SUFFICIENT INSTRUCTIONS FOR PERFORMING THE TEST. ADDITIONALLY, THERE WAS NO REPORT OF A DEATH AND/OR SERIOUS INJURY AS A RESULT OF THE CUSTOMER'S OFF-LABEL PRACTICE. (B)(4).