PRISM CHAGAS

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

Description of Event or Problem

THE CUSTOMER OBSERVED MULTIPLE FALSELY REACTIVE RESULTS WHILE USING THE PRISM CHAGAS REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID NUMBERS WERE PROVIDED AND THE CUSTOMER STATED REPEAT REACTIVE SPECIMENS DID NOT CONFIRM (CONFIRMATORY TESTING NEGATIVE), HOWEVER SPECIFIC RESULTS VALUES WERE NOT PROVIDED. (B)(6). NO IMPACT TO PATIENT OR DONOR MANAGEMENT WERE REPORTED.

Additional Manufacturer Narrative

EVALUATION OF THE CUSTOMER ISSUE INCLUDED A COMPLAINT TEXT REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, DEVICE HISTORY REVIEW, LABELING REVIEW, AND FIELD DATA REVIEW. THE PRODUCT WAS NOT RETURNED. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PATIENT SAMPLE WAS AVAILABLE FOR RETURN, THEREFORE CLINICAL SPECIFICITY TESTING OF NEGATIVE CONTROL REPLICATES WAS PERFORMED USING IN-HOUSE RETAINED KITS STORED AT THE RECOMMENDED STORAGE CONDITION. SPECIFICITY TESTING MET ALL SPECIFICATIONS. ABBOTT LINK WORLD WIDE DATA WAS USED TO EVALUATE HISTORICAL PRODUCT FIELD PERFORMANCE. PATIENT DATA WAS ANALYZED AND THE INITIAL AND REPEAT REACTIVE RATE OF THE LIKELY CAUSE LOT WAS REVIEWED. THE INITIAL REACTIVE RATE, REPEAT REACTIVE RATE AS SPECIFICITY SPECIFICATIONS OF THE COMPLAINT LOT WERE ACCEPTABLE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND.

Additional Manufacturer Narrative

CONCOMITANT MEDICAL PRODUCTS CHANGED A SECOND ANALYZER SERIAL NUMBER, (B)(4), WAS ADDED. DEVICE EVALUATED BY MFR: AN EVALUATION IS IN PROCESS.