ANALYTICAL E MODULE

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN THE (B)(6).

Additional Manufacturer Narrative

THE CUSTOMER RETURNED THREE SAMPLES FOR INVESTIGATION. TESTING WAS PERFORMED USING ORTHO SAVE ELISA, (B)(6) AND ELECSYS RETENTION LOTS 168867, 169318, AND 169909. ALL SAMPLES WERE (B)(6) USING THE RETENTION LOTS AND INNOLIA SCORE, BUT (B)(6) WITH THE ORTHO METHOD. THE SAMPLES WERE CONSIDERED (B)(6) WITH THE ELECSYS ASSAYS.

Description of Event or Problem

THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE ANTIBODY TO (B)(6) RESULT FOR ONE PATIENT ON THEIR E-MODULE. ON (B)(6) 2012, THE PATIENT'S (B)(6) RESULT WAS (B)(6). ON THE DAY OF THE EVENT, THE PATIENT'S (B)(6) RESULT WAS (B)(6). THE CUSTOMER IS QUESTIONING THE PATIENT'S (B)(6) RESULT AS THE PATIENT WAS PREVIOUSLY KNOWN TO BE (B)(6). THE PATIENT'S SAMPLE WAS THEN TESTED ON AN ARCHITECT ANALYZER AND AN ETI-MAX 300 ANALYZER AND THE RESULTS WERE (B)(6). THE CUSTOMER STATED THE RESULTS WERE DISCUSSED WITH THE GENERAL PRACTITIONER AND HE WAS ADVISED THE LABORATORY COULD NOT CONFIRM WHICH RESULTS WERE CORRECT. THE CUSTOMER WAS NOT TREATED BASED ON THE (B)(6) RESULT AND THERE WERE NO ADVERSE EVENTS. THE AHCV REAGENT LOT NUMBER WAS 169318 AND THE EXPIRATION DATE WAS NOT PROVIDED.