ARCHITECT CMV IGG

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PREGNANT FEMALE PATIENT GENERATED ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2025: FIRST RESULT = > 250 AU/ML (B)(6) 2025: SECOND RESULT (1:10 DILUTION) = 117 AU/ML; REPEAT RESULT UNDILUTED = < 6 AU/ML; REPEAT RESULT UNDILUTED AGAIN = < 6 AU/ML ALL TESTING WAS DONE ON THE SAME INSTRUMENT. SAMPLE WAS TESTED ON THE COBAS PLATFORM AND GENERATED A NEGATIVE RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT CMV IGG, 06C15-30, ABBOTT IRELAND DIAGNOSTICS DIVISION, SLIGO MANUFACTURING SITE TO ARCHITECT I2000SR PROCESSING MODULE, 03M74-97, IRVING IA/CC MANUFACTURING SITE. MDR NUMBER 3016438761-2025-00606 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PREGNANT FEMALE PATIENT GENERATED ON THE ARCHITECT (B)(6) ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): ON (B)(6) 2025: FIRST RESULT = > 250 AU/ML. ON (B)(6) 2025: SECOND RESULT (1:10 DILUTION) = 117 AU/ML; REPEAT RESULT UNDILUTED = < 6 AU/ML; REPEAT RESULT UNDILUTED AGAIN = < 6 AU/ML. ALL TESTING WAS DONE ON THE SAME INSTRUMENT. SAMPLE WAS TESTED ON THE COBAS PLATFORM AND GENERATED A NEGATIVE RESULT. 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. A1 - PATIENT IDENTIFIER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. E1 - POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.