PRODUCT EVALUATION WAS PERFORMED TO INVESTIGATE THIS ISSUE. THE LOT SEARCH DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR THE LIKELY CAUSE LOT AND THE TREND REVIEW DETERMINED THAT COMPLAINT ACTIVITY WAS NOT ATYPICAL FOR THE ISSUE UNDER INVESTIGATION. ADDITIONALLY, ACCURACY TESTING WAS COMPLETED USING LIKELY CAUSE LOT 09020LP36 AND FOUR PANELS WITH KNOWN CONCENTRATIONS OF INSULIN. ALL PANELS WERE WITHIN THE RESPECTIVE ACCEPTANCE RANGES. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ARCHITECT INSULIN REAGENT LOT 09020LP30 IS PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. NO DEFICIENCY WAS IDENTIFIED RELATED TO THE ALLEGED MALFUNCTION REPORTED BY THE CUSTOMER.
N
Patient 1
CORRECTION WAS ADDED (PRODUCT LOT NUMBER WAS CORRECTED FROM 09020LP30 TO 09020LP36).
N
Patient 1
THIS REPORT IS BEING SUBMITTED TO REFERENCE A PREVIOUS REPORT (3002809144-2012-00026) WHICH WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT MANUFACTURER SITE. (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WIL BE SUBMITTED IN A FOLLOW-UP REPORT.
D
Patient 1
THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED A FALSELY ELEVATED RESULT FOR THE ARCHITECT INSULIN ASSAY. A RESULT OF 119.2 UU/ML WAS REPEATED AT 10.34 UU/ML USING A DIFFERENT (NON-ABBOTT) METHOD. THE PATIENT WAS MONITORED AND HAD A HISTORY OF INSULIN RESULTS AROUND 10 UU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.