ARCHITECT I2000SR ANALYZER

Description of Event or Problem

THE CUSTOMER STATED THAT THEY HAD AT LEAST 3 PATIENTS WITH FALSE POSITIVE CMV IGG RESULTS GENERATED BY THE ARCHITECT I2000 ANALYZER. THE RESULTS WERE NEGATIVE WITH ANOTHER TECHNIQUE AND WHEN REPEATED A THIRD TIME ON THE ARCHITECT THEY WERE NEGATIVE. THE CUSTOMER REPORTED THE NEGATIVE RESULTS. NO SPECIFIC DATA WAS PROVIDED BY THE CUSTOMER. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

A CORRECTION TO MANUFACTURE NAME, CITY AND STATE WAS MADE AS IT WAS MISSING IN THE FOLLOWUP-01 REPORT.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

A FIELD SERVICE REPRESENTATIVE (FSR) REPLACED AND CALIBRATED THREE WASH ZONE NEEDLES. HE ALSO OBSERVED A LEAKING TRIGGER PUMP WHICH WAS REPLACED. IN A SUBSEQUENT VISIT, THE SAMPLE, R1, AND R2 PROBES WERE REPLACED TO RESOLVE THE CUSTOMER ISSUE. THE CUSTOMER RECENTRIFUGED THE PATIENT SAMPLES AND REPEATED TESTING. NEGATIVE RESULTS WERE CONFIRMED AND REPORTED. PROBE REPLACEMENT RESOLVED THE ISSUE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE CUSTOMER ISSUE. THE ARCHITECT CMV IGG REAGENT PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.