THE CUSTOMER STATES THAT (B)(6) RESULTS HAVE BEEN GENERATED WITH THE ARCHITECT CMV IGM ASSAY. ONE PATIENT GENERATED AN INITIAL (B)(6) INDEX RESULT OF 1.37 THAT RETESTED AT 1.42 INDEX AFTER THE CUSTOMER RECALIBRATED THE ASSAY WITH A DIFFERENT LOT OF CALIBRATOR. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THE SAMPLE WAS THEN TESTED ON A NON-ABBOTT PLATFORM AND GENERATED A NEGATIVE INDEX RESULT OF 0.41. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. A SERVICE CALL WAS INITIATED.
N
Patient 1
(B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE
N
Patient 1
(B)(4). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE CUSTOMER SITE AND FOUND THAT THE SAMPLE PROBE WAS LOOSE AND THAT BUFFER BUILD UP WAS PRESENT ON BOTH WASH ZONES. THE FSR REPLACED AND CALIBRATED THE SAMPLE, STAT, REAGENT 1 AND REAGENT 2 PROBES. ADDITIONALLY, THE FSR REPLACED BOTH WASH ZONE MANIFOLDS. THE FSR INDICATES THAT THE REPLACEMENT OF THE COMPONENTS RESOLVED THE ISSUE AND THAT THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-108), JANUARY 2010 AND THE ARCHITECT CMV IGM ASSAY PACKAGE INSERT ((B)(4)) CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.