ARCHITECT CMV IGG REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND IN-HOUSE TESTING FOR ARCHITECT CMV IGG LOT NUMBER 64354FZ00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING FOR THE CMV IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 64354FZ00. IN-HOUSE TESTING WAS PERFORMED WITH A RETAINED KIT OF LOT 64354FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A PRODUCT LABELLING STATES IF THE ARCHITECT CMV IGG RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., RESULTS OF OTHER TESTS (CMV IGM, CMV IGG AVIDITY), CLINICAL IMPRESSIONS, ETC. A MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CMV IGG LOT NUMBER 64354FZ00.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS ON ONE PREGNANT PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6)2024, SID (B)(6), INITIAL=141.331 AU/ML (>OR=6.0 AU/ML=REACTIVE) /REPEATED=NEGATIVE (NO ACTUAL RESULTS PROVIDED) /REPEATED ON (B)(6)2024=0.521 AU/ML. ADDITIONAL INFORMATION PROVIDED: IGM=0.29 INDEX /REPEATED ON (B)(6) 2024=0.2852 INDEX ON (B)(6)2024 REDRAWN SAME PATIENT: SID (B)(6) IGG=0.48 AU/ML; IGM=0.258 INDEX THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6).AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS ON ONE PREGNANT PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024, SID (B)(6), INITIAL=141.331 AU/ML (>OR=6.0 AU/ML=REACTIVE) /REPEATED=NEGATIVE (NO ACTUAL RESULTS PROVIDED) /REPEATED ON (B)(6) 2024=0.521 AU/ML ADDITIONAL INFORMATION PROVIDED: IGM=0.29 INDEX /REPEATED ON (B)(6) 2024=0.2852 INDEX ON (B)(6) 2024 REDRAWN SAME PATIENT: SID (B)(6), IGG=0.48 AU/ML; IGM=0.258 INDEX THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.