ARCHITECT TACROLIMUS
Received Apr 22, 2020 · Event occurred Apr 2, 2020
Report 1415939-2020-00035 · MDR key 9985476
Device
Generic name
Tacrolimus
Manufacturer
Abbott LaboratoriesModel number
1L77-25Catalog number
01L77-25
Lot number
10002M800
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TACROLIMUS RESULTS FOR ONE PATIENT. RESULTS PROVIDED: INITIAL = 44NG/ML, REPEAT = 16NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
A REVIEW OF TICKETS FOR LOT 10002M800 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY OR TRENDS RELATED TO THE FALSELY ELEVATED RESULTS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERFORMED WITH A RETAINED KIT OF LOT 10002M800 AND A TACROLIMUS PANEL. ALL ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES THE PRODUCT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TACROLIMUS REAGENT, LOT 10002M800.