IMMULITE 2000 XPI CMV IGG (CVG)

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULT FOR A PATIENT IN (B)(6) 2022. THE PATIENT WAS TESTED AGAIN IN (B)(6) 2022 ON THE ATELLICA IM CMV IGG AND THE RESULT WAS POSITIVE. THE CUSTOMER THEN TESTED A SAMPLE ON THE ATELLICA IM CMV IGG ASSAY FROM THIS PATIENT THAT WAS DRAWN IN 2019 AND THE RESULT WAS POSITIVE. BASED ON THE POSITIVE ATELLICA IM CMV IGG RESULTS, THE CUSTOMER ASSUMES THAT THE NEGATIVE IMMULITE 2000 XPI CMV IGG RESULT IS DISCORDANT. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS. " SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER OBSERVED A NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULT FOR A PATIENT IN (B)(6) 2022. THE PATIENT WAS TESTED AGAIN IN (B)(6) 2022 ON THE ATELLICA IM CMV IGG AND THE RESULT WAS POSITIVE. THE CUSTOMER THEN TESTED A SAMPLE ON THE ATELLICA IM CMV IGG ASSAY FROM THIS PATIENT THAT WAS DRAWN IN 2019 AND THE RESULT WAS POSITIVE. BASED ON THE POSITIVE ATELLICA IM CMV IGG RESULTS, THE CUSTOMER ASSUMES THAT THE NEGATIVE IMMULITE 2000 XPI CMV IGG RESULT IS DISCORDANT. IT IS UNKNOWN IF THE NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NEGATIVE CMV IGG PATIENT RESULT.

Additional Manufacturer Narrative

THE INITIAL MDR 1219913-2022-00300 WAS FILED ON SEPTEMBER 14, 2022. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVED A NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) RESULT FOR A PATIENT IN APRIL 2022. THE PATIENT WAS TESTED AGAIN IN AUGUST 2022 ON THE ATELLICA IM CMV IGG AND THE RESULT WAS POSITIVE. THE CUSTOMER THEN TESTED A SAMPLE ON THE ATELLICA IM CMV IGG ASSAY FROM THIS PATIENT THAT WAS DRAWN IN 2019 AND THE RESULT WAS POSITIVE. BASED ON THE POSITIVE ATELLICA IM CMV IGG RESULTS, THE CUSTOMER ASSUMES THAT THE NEGATIVE IMMULITE 2000 XPI CMV IGG RESULT IS DISCORDANT. ADDITIONAL INFORMATION - SEPTEMBER 23, 2022: IT WAS ORIGINALLY UNKNOWN WHETHER THE INITIAL RESULT WAS REPORTED BUT IT HAS BEEN CONFIRMED THAT THE ORIGINAL NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE CUSTOMER PROVIDED INFORMATION THAT THE SAMPLE IS FROM A PREGNANT PATIENT. SIEMENS HAS COMPLETED THE INVESTIGATION INTO AN INITIAL NEGATIVE IMMULITE 2000 XPI CMV IGG (CVG) SAMPLE THAT REPEATED REACTIVE ON THE ATELLICA IM CMV IGG ASSAY. SIEMENS WAS UNABLE TO REVIEW FILES AS FILES ARE NO LONGER AVAILABLE. IN HOUSE RELEASE DATA WAS REVIEWED AND THERE WERE NO SAMPLES THAT CHANGED CLINICAL INTERPRETATION FROM LOT 365 TO LOT 366. SIEMENS IS UNABLE TO DETERMINE IF THE SAMPLE WOULD REPEAT ON LOT 365 AS THE SAMPLE WAS NOT REPEATED. SIEMENS REQUESTED SAMPLES FOR TESTING HOWEVER NO SAMPLES WERE PROVIDED. THERE ARE NO FURTHER REPORTED DISCREPANTS AS CUSTOMER MOVED TESTING TO ATELLICA IM PLATFORM. SYSTEM IS OPERATIONAL FOR ALL OTHER ASSAYS AND THERE IS NO FURTHER ACTION REQUIRED. NO PRODUCT NON CONFORMANCE IDENTIFIED.