COBAS E411 RACK SYSTEM

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR A TOTAL OF 3 PATIENT SAMPLES TESTED FOR ANTIBODY TO (B)(6). OF THE THREE SAMPLES, ONE WAS FOUND TO HAVE AN ERRONEOUS RESULT. THE SAMPLE INITIALLY RESULTED AS 0.214 COI, WHICH IS CONSIDERED (B)(6). THE SAMPLE WAS ALSO TESTED ON (B)(6) 2013, USING AN ELISA METHOD AND RESULTED AS 1.748 COI WHICH IS CONSIDERED (B)(6). A RESULT OF "INDETERMINATE" WAS RELEASED OUTSIDE OF THE LABORATORY SINCE THERE WERE 2 DIFFERENT RESULTS WITH THE DIFFERENT METHODS. IT WAS ASKED, BUT NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. NO ADVERSE EVENTS WERE ALLEGED. THE ANTI (B)(6) REAGENT LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED.

Additional Manufacturer Narrative

A SAMPLE FROM THE AFFECTED PATIENT WAS INVESTIGATED USING SEVERAL DIFFERENT METHODS, INCLUDING ROCHE (B)(6) AND (B)(6) II, ORTHO ELISA, MIKROGEN BLOT, AND INNO-LIA HCV. INVESTIGATIONS DETERMINED THAT THE CUSTOMER'S NEGATIVE RESULT WITH THE ROCHE (B)(6) ASSAY WAS REPRODUCED. CONSIDERING THE DIFFERENT RESULTS, THE SAMPLE MOST LIKELY IS NEGATIVE FOR (B)(6). IT IS POSSIBLE TO RECEIVE A FALSE NEGATIVE RESULT FOR THE ASSAY WHEN THE PATIENT HAS A FRESH INFECTION (SEROCONVERSION PHASE), BUT SEROCONVERSION COULD BE EXCLUDED AS A POSSIBILITY.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).