ELECSYS CMV IGG ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). BOTH SAMPLES WERE REQUESTED FOR INVESTIGATION. THE SAMPLES WERE SUBMITTED FOR INVESTIGATION AND TESTED WITH CMV IGG REAGENT LOT 406216 ON AN E601 MODULE. SAMPLE FROM (B)(6) 2020: CMV IGG: 0.15 IU/ML(NEGATIVE) WITH DATA FLAG. SAMPLE FROM (B)(6) 2020: CMV IGG: 0.15 IU/ML(NEGATIVE) WITH DATA FLAG. THE CUSTOMER'S RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT NEGATIVE RESULTS FOR 2 BLOOD BANK SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS 6000 E 601 MODULE COMPARED TO THE DIASORIN METHOD. THE INITIAL RESULT FROM THE E601 MODULE WAS 0.142 COI (NEGATIVE). THE RESULT FROM THE DIASORIN METHOD WAS 23.3 U/ML (POSITIVE). ON (B)(6) 2020 A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE E601 MODULE WAS 0.150 COI (NEGATIVE) WITH A DATA FLAG. THE RESULT FROM THE DIASORIN METHOD WAS 24.7 U/ML (POSITIVE). THE NEGATIVE RESULTS WERE REPORTED TO THE BLOOD BANK AND QUESTIONED. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

CALIBRATION DATA FROM AROUND THE DATE OF EVENT WAS NOT PROVIDED. QC RESULTS WERE ACCEPTABLE. BOTH SAMPLES FROM THE PATIENT WERE INVESTIGATED FURTHER USING THE RECOMLINE CMV IGG ASSAY AND THE RESULTS WERE BOTH NEGATIVE. THE CUSTOMER'S CMV IGG RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE BOTH WITH THE ELECSYS ASSAY AND THE RECOMLINE ASSAY. THERE IS NO EVIDENCE TO SUGGEST IMMUNITY TO CMV FOR THIS PATIENT. THE REAGENT PERFORMS WITHIN SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.