PRISM CHAGAS
Received May 26, 2017 · Event occurred Feb 21, 2017
Report 1415939-2017-00117 · MDR key 6594069
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
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED A BLOOD DONOR WHO TESTED REACTIVE FOR PRISM ANTI-T.CRUZI AND WAS ESA CHAGAS POSITIVE. THE SAMPLE WAS SENT FOR FOLLOW-UP TESTING BY THE CDC FOR T.CRUZI AB EIA AND T.CRUZI AB IB (TESA) WHICH WERE BOTH NEGATIVE. THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT. THERE WAS NO ADDITIONAL DONOR INFORMATION PROVIDED.
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 FOR THE ABBOTT PRISM CHAGAS LOT 68048M500 WAS PERFORMED FOR SPECIFICITY. A TOTAL OF 443,845 SAMPLES WERE TESTED ACROSS MULTIPLE CUSTOMER SITES AND THE INITIAL AND REPEAT (B)(4), RESPECTIVELY, WHICH ARE LESS THAN THE PRISM CHAGAS PACKAGE INSERT UPPER 95% CONFIDENCE INTERVALS OF 0.28% AND 0.23%. THEREFORE, THE LOT IS MEETING LABELING CLAIMS FOR CLINICAL SPECIFICITY. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.