THE EVALUATION BEGAN WITH ACCURACY TESTING USING LIKELY CAUSE AXSYM ETHANOL REAGENT LOT 08551M500. TESTING MET ALL ACCEPTANCE CRITERIA. A REVIEW OF INFORMATION FROM THE CUSTOMER SITE REGARDING A VISIT FROM THE ABBOTT FIELD SERVICE REPRESENTATIVE FOUND THAT THE AXSYM PLUS ANALYZER IS OPERATING AS EXPECTED AND THE CUSTOMER'S ISSUE WAS MOST LIKELY DUE TO THE INTEGRITY OF THE SAMPLES INVOLVED. NO REOCCURRENCE OF THE ISSUE HAS BEEN SEEN. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE AXSYM REA ETHANOL ASSAY PACKAGE INSERT CONTAINS INFORMATION REGARDING SAMPLE HANDLING PROCEDURES TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THE CURRENT EVALUATION, THE AXSYM REA ETHANOL REAGENT LOT 08551M500 IS PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED.
D
Patient 1
THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL AXSYM ETHANOL ASSAY RESULT OF 5.101 MG/DL. THE RESULT DID NOT FIT THE PATIENT'S CLINICAL CONDITION AND THE SAMPLE WAS RETESTED. THE RETEST RESULT WAS 176.77 MG/DL, WHICH CORRESPONDED TO THE PATIENT'S CONDITION AND THIS RESULT WAS REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
N
Patient 1
AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).