ARCHITECT I2000 ANALYZER

Additional Manufacturer Narrative

(B)(4). OTHER (B)(4): THE CUSTOMER PERFORMED TROUBLESHOOTING WITH THE HELP OF THE ABBOTT TECHNICAL SUPPORT OFFICER (TSO). THE CUSTOMER CLEANED THE WASH ZONES DUE TO SALT DEPOSITS. SEVERAL GRAVIMETRIC TESTS WERE PERFORMED AND THE CUSTOMER INDICATED THAT THE RESULTS WERE ACCEPTABLE. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO LIQUID LEAKING FROM THE ANALYZER. THE FSR REPAIRED THE LEAK AND REPORTED THE ANALYZER WAS PERFORMING ACCORDING TO SPECIFICATIONS. SUBSEQUENTLY AS A RESULT OF TECHNICAL EVALUATIONS NOT RELATED TO THIS COMPLAINT ISSUE, THE ARCHITECT ANALYZER (B)(4) WAS DE-INSTALLED FROM THE CUSTOMER SITE. THE CUSTOMER RECEIVED A REPLACEMENT ANALYZER, (B)(4). IN ADDITION CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT (B)(4) ASSAY PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE OF ERRATIC RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THIS IS THE FINAL REPORT.

Description of Event or Problem

THE ACCOUNT STATED THAT THE ARCHITECT ANALYZER GENERATED AN INITIAL NEGATIVE (B)(6) RESULT OF S/CO=0.815 ON A DONOR SAMPLE. THE SAMPLE WAS REPEATED BECAUSE THE RESULT WAS HIGHER THAN THE AVERAGE READ OF DONORS. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER WITH (B)(6) RESULTS OF 1.168 (PLASMA BUFFY SAMPLE) AND 1.173 (CENTRIFUGED SERUM SAMPLE). THE SAME REAGENT LOT NUMBER WAS USED ON BOTH ANALYZERS. THE NEGATIVE RESULTS WERE NOT REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

(B)(4).THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.