ARCHITECT CYCLOSPORINE REAGENT KIT
Received Mar 27, 2025 · Event occurred Mar 11, 2025
Report 1415939-2025-00010 · MDR key 21707083
Device
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 = 61 NG/ML. (B)(6) 2025 = 611 / 488.9 / 517.7 / 510 NG/ML, ANOTHER INSTRUMENT = 536 NG/ML. (B)(6) 2025 = 52 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CYCLOSPORINE ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT CYCLOSPORINE REAGENT LOT 69373FP00 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 = 61 NG/ML. (B)(6) 2025 = 611 / 488.9 / 517.7 / 510 NG/ML, ANOTHER INSTRUMENT = 536 NG/ML. (B)(6) 2025 = 52 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.