ARCHITECT CYCLOSPORINE REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS FOR ONE 6 YEAR OLD MALE PATIENT DIAGNOSED WITH IDIOPATHIC APLASTIC ANEMIA. THE PATIENT IS ON THE FOLLOWING MEDICATION, SANDIMMUN 60 MG TWICE DAILY, NOXAFIL (POSACONAZOLE), PREDNISONE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2026 = 1335.6 AND 1420.8 NG/ML REPEATED AGAIN ON (B)(6) 2026 = 1148.2 AND 1107.7 NG/ML. SID (B)(6) PROCESSED ON (B)(6) 2026 RESULT = 116 NG/ML. HISTORY SINCE 29 MAY, MAXIMUM VALUE 200 NG/ML. UREA, CREATININE, LIVER ENZYMES WITHIN NORMAL RANGE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3R30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L75 WITH 510K/PMA/BLA NUMBER K080751.