COBAS 6000 E601 MODULE

Description of Event or Problem

THE CUSTOMER, A BLOOD BANK, RECEIVED QUESTIONABLE ANTIBODY TO (B)(6) ON THEIR E601 ANALYZER. THE CUSTOMER WAS DOING A COMPARISON STUDY BETWEEN THE E601 AND A MUREX ANALYZER. THE CUSTOMER PROVIDED DATA FOR 16 SAMPLES, OF WHICH 12 HAD DISCREPANT RESULTS. SAMPLE 1'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS 0.07 WHICH WAS CONSIDERED (B)(6). SAMPLE 2'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS 0.08 WHICH WAS CONSIDERED (B)(6). SAMPLE 3'S MUREX RESULT WAS 1.02 WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 4'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 5'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 6'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 7'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 8'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 9'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 10'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 11'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLE 12'S MUREX RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). THE E601 RESULT WAS (B)(6) WHICH WAS CONSIDERED (B)(6). SAMPLES WERE SENT FOR RIBA TESTING AND ALL RIBA RESULTS WERE (B)(6). IT IS UNKNOWN WHICH SAMPLES WERE SENT FOR RIBA TESTING AND CLARIFICATION HAS BEEN REQUESTED. IT IS UNKNOWN IF THE RESULTS WERE USED FOR DIAGNOSTIC PURPOSES. IT IS UNKNOWN IF THERE WERE ANY ADVERSE EVENTS. THE (B)(6) REAGENT LOT NUMBER WAS (B)(4) AND THE EXPIRATION DATE WAS NOT PROVIDED.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(4).

Additional Manufacturer Narrative

THERE WERE NO SAMPLES AVAILABLE TO BE RETURNED FOR INVESTIGATION. THE CUSTOMER DID FURTHER TESTING WITH WESTERN BLOT (RIBA) AND PCR ON SAMPLES 1, 7, 8, 10, AND 11 THAT WERE NEGATIVE ON THE ELECSYS TEST METHOD. THESE SAMPLES WERE CONFIRMED TO BE TRUE NEGATIVE RESULTS BASED ON THE ADDITIONAL TESTING. FOR THE OTHER SAMPLES IN QUESTION, NO ADDITIONAL TESTING DATA WAS PROVIDED AND NO CONCLUSIONS COULD BE DRAWN.