ARCHITECT CMV IGG REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 IGG NEGATIVE; IGM POSITIVE: 2.95 S/CO. (B)(6) 2024 IGG NEGATIVE, IGM POSITIVE: 2.51 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TICKET SEARCH BY LOT INDICATES NORMAL COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY RELATED TREND REGARDING COMMONALITIES FOR COMPLAINT LOT NUMBER AND ISSUE. CLINICAL SENSITIVITY TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELLING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG ASSAY WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 IGG NEGATIVE; IGM POSITIVE: 2.95 S/CO. (B)(6) 2024 IGG NEGATIVE, IGM POSITIVE: 2.51 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.