ARCHITECT CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR A 30-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<6.00 AU/ML IS NONREACTIVE, >/=6.00 AU/ML IS REACTIVE): INITIAL RESULT, ON (B)(6)2024, WAS 8.5, REPEAT RESULTS WERE 8.7 AND 8.6 AU/ML; IGM RESULT WAS <0.85, WHICH IS NEGATIVE. THE PATIENT¿S PREVIOUS RESULT, ON (B)(6)2024, WAS LESS THAN 6 AU/ML; IGM RESULT WAS <0.85, WHICH IS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ARCHITECT CMV IGG RESULTS 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 TESTING OF RETAINED REAGENT KIT OF THE COMPLAINT LOT NUMBER. A REACTIVE RESULT OF 8.5 AU/ML WAS RETURNED ON THE (B)(6)2024 FOR A PATIENT THAT WAS PREVIOUSLY NONREACTIVE (B)(6)2024). THE PATIENT WAS REPEATEDLY NONREACTIVE FOR CMV IGM. CMV IGG RESULTS OF 8.7 AND 8.6 AU/ML WERE RETURNED UPON RETEST. SPECIMENS WITH CONCENTRATION VALUES <6.0 AU/ML ARE CONSIDERED NONREACTIVE FOR IGG ANTIBODIES TO CMV. SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE FOR IGG ANTIBODIES TO CMV. IT IS RECOMMENDED TO CONFIRM RESULTS OF SPECIMENS WITH CONCENTRATION VALUES BETWEEN 6.0 AU/ML AND 15.0 AU/ML USING A CMV IGM TEST, OR A SECOND SAMPLE SHOULD BE TAKEN, IF POSSIBLE, WITHIN A REASONABLE PERIOD OF TIME (E.G. TWO WEEKS) AND USED TO REPEAT ARCHITECT CMV IGG TESTING. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 61380FZ00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. PER PRODUCT LABELING, 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. THE TICKET NOTES STATE THAT THE CUSTOMER REPORTED THE RESULT AS POSITIVE (DUE TO THE SIMILAR RESULTS ACROSS THREE SEPARATE TESTS). LABELING PROVIDES INSTRUCTIONS ON HOW TO PROCEED WHEN CMV IGG RESULTS OF BETWEEN 6.0 AU/ML AND 15.0 AU/ML ARE RETURNED. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, ARCHITECT CMV IGG, LOT NUMBER 61380FZ00, IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR A 30-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<6.00 AU/ML IS NONREACTIVE, >/=6.00 AU/ML IS REACTIVE): INITIAL RESULT, ON (B)(6) 2024, WAS 8.5, REPEAT RESULTS WERE 8.7 AND 8.6 AU/ML; IGM RESULT WAS <0.85, WHICH IS NEGATIVE. THE PATIENT¿S PREVIOUS RESULT, ON (B)(6) 2024, WAS LESS THAN 6 AU/ML; IGM RESULT WAS <0.85, WHICH IS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.