ARCHITECT TACROLIMUS REAGENT KIT
Received Apr 11, 2023 · Event occurred Mar 22, 2023
Report 1415939-2023-00025 · MDR key 16717274
Device
Generic name
Enzyme Immunoassay, Tracrolimus
Manufacturer
Abbott LaboratoriesModel number
1L77-25Catalog number
01L77-25
Lot number
44086FP00
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, PATIENT IDENTIFIER = SID= (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TACROLIMUS RESULTS ON ONE KIDNEY TRANSPLANT PATIENT. THE RESULTS PROVIDED WERE: RENAL TRANSPLANT PERFORMED ON (B)(6) AND TACROLIMUS ON (B)(6)= AROUND < 10 NG/ML ON (B)(6) 2023 SID (B)(6) 1:1=> 30 NG/ML; 1:4=60.30 NG/ML ON (B)(6) 2023 SID (B)(6) 1:1= >30 NG/ML; 1:2= >60 NG/ML; 1:3=77.1 NG/ML; 1:4=76.6 NG/ML ON (B)(6) 2023 SID (B)(6) 1:1=>30 NG/ML; 1:3=39.60 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.