PRISM CHAGAS
Received May 24, 2017
Report 1415939-2017-00114 · MDR key 6587614
Device
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
EVALUATION OF COMPLAINT DATA FOR THE LOTS IDENTIFIED NORMAL COMPLAINT ACTIVITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. A REVIEW OF THE PRISM METRICS FIELD DATA INDICATES THAT THE INITIAL AND REPEAT REACTIVE RATES FOR THE ABBOTT PRISM CHAGAS LOT 68048M500 WHICH IS LESS THAN THE PACKAGE INSERT'S UPPER 95% CONFIDENCE INTERVALS. LABELING CLAIMS WERE MET FOR SPECIFICITY; THERE IS NO PRODUCT DEFICIENCY. A MALFUNCTION WAS NOT IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ADDITIONAL INFORMATION SUSPECT MEDICAL DEVICE; CONCOMITANT: ABBOTT ESA CHAGAS; LIST # 08L34-68; LOT # A00001300.
Description of Event or Problem
THE CUSTOMER REPORTED INCREASE IN (B)(6) PRISM CHAGAS AND PRISM HCV RESULTS IN (B)(6)2017. OF 14 RR CHAGAS SAMPLES 7 WERE (B)(6). SUPPLEMENTAL/CONFIRMATORY TESTING WAS PERFORMED WITH ORTHO CHAGAS (2 (B)(6), 5 NOT TESTED); ORTHO HCV ALL 7 (B)(6); ABBOTT CHAGAS ESA (6 (B)(6), ONE NOT TESTED). THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL DONOR INFORMATION PROVIDED.