ARCHITECT I2000 ANALYZER

Description of Event or Problem

THE CUSTOMER STATED THAT A NEGATIVE ARCHITECT CMV IGG RESULT OF 0 AU/ML WAS REPORTED FOR A PATIENT SAMPLE ON (B)(6) 2011. THE SAMPLE RETESTED POSITIVE AT >250 AU/ML. THE INITIAL NEGATIVE RESULT WAS AMENDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

Additional Manufacturer Narrative

AN EVALUATION WAS PERFORMED WHICH CONSISTED OF A REVIEW OF THE CUSTOMER INFORMATION PROVIDED, INSTRUMENT SERVICE HISTORY, AND A REVIEW OF CURRENT ARCHITECT LABELING. SUBSEQUENT TO THE FALSE NEGATIVE RESULT BEING GENERATED, ABBOTT FIELD SERVICE PERFORMED MULTIPLE INSTRUMENT CHECKS AS WELL AS REROUTED THE PRE-TRIGGER TUBING AND RESEATED THE PRE-TRIGGER VALVE CONNECTORS. A REVIEW OF TICKET HISTORY FOR ARCHITECT (B)(4) IDENTIFIED NO ADDITIONAL REPORTS OF UNRESOLVED ERRATIC/IMPRECISE RESULTS SUBSEQUENT TO FIELD SERVICE PERFORMING MULTIPLE INSTRUMENT CHECKS, REROUTING THE PRE-TRIGGER TUBING AND RESEATING THE PRE-TRIGGER VALVE CONNECTORS. ASSOCIATED ARCHITECT LABELING ADDRESSES SAMPLE HANDLING/SAMPLE INTEGRITY, MAINTENANCE PROCEDURES AND POTENTIAL CAUSES OF ERRATIC/IMPRECISE RESULTS ON THE ARCHITECT I SYSTEM. NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED RELATIVE TO ERRATIC RESULTS ON THE ARCHITECT I2000. A DEFICIENCY OF THE ARCHITECT I2000 WAS NOT IDENTIFIED.