THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE ARCHITECT INSULIN ASSAY REAGENT USED AT THEIR SITE. THEREFORE, A HISTORICAL REVIEW OF ACCURACY TESTING WAS PERFORMED FOR THIS LIST NUMBER. ALL RESULTS WERE WITHIN SPECIFICATION, INDICATING THE ASSAY IS CAPABLE OF ACCURATELY DETECTING VARIOUS LEVELS OF THE INSULIN ANALYTE. 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 ARCHITECT INSULIN ASSAY PACKAGE INSERT (LIST 08K41) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THE CURRENT INVESTIGATION, THE ARCHITECT INSULIN ASSAY IS PERFORMING AS DESIGNED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.
D
Patient 1
THE CUSTOMER OBSERVED AN ALLEGED FALSELY ELEVATED ARCHITECT INSULIN ASSAY RESULT ON ONE PATIENT. THE PATIENT IS NOT DIABETIC AND THE CUSTOMER DID NOT PROVIDE ANY REASON WHY THE INSULIN LEVEL FOR THIS PATIENT WAS BEING MONITORED. IN THE MORNING OF (B)(6) 2012, THE PATIENT GENERATED AN ARCHITECT INSULIN RESULT OF 13.3 UU/ML (SAMPLE #1). THE EVENING SAMPLE (#2) OF THAT SAME DATE GENERATED A RESULT OF 633 UU/ML (AUTO-DILUTION). THE FOLLOWING MORNING, SAMPLE (#3) GENERATED A RESULT OF 143 UU/ML. THE CUSTOMER IS QUESTIONING THE ELEVATED RESULT OF 633 UU/ML; HOWEVER, THE PATIENT'S PHYSICIAN DID NOT COMMENT ON ANY OF THE INSULIN RESULTS. 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).