PRISM CHAGAS
Received Feb 15, 2019
Report 1415939-2019-00010 · MDR key 8344022
Device
Product problems
- False Positive Result
- False Positive Result
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. (B)(6).
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ABBOTT PRISM CHAGAS RESULTS. SAMPLE ID (B)(6) : (B)(6) YEAR OLD MALE, PRISM CHAGAS REPEAT REACTIVE AND NEGATIVE ON CHAGAS ORTHO SUMMIT ASSAY SAMPLE ID (B)(6): (B)(6) YEAR OLD MALE, PRISM CHAGAS REPEAT REACTIVE AND NEGATIVE ON CHAGAS ORTHO SUMMIT ASSAY SAMPLE ID (B)(6): (B)(6) YEAR OLD MALE, PRISM CHAGAS REPEAT REACTIVE AND NEGATIVE ON CHAGAS ORTHO SUMMIT ASSAY NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
REVIEW OF COMPLAINT ACTIVITY DID NOT IDENTIFY ANY ADVERSE TRENDS FOR THE PRISM CHAGAS ASSAY. NORMAL COMPLAINT ACTIVITY WAS IDENTIFIED FOR THE LIKELY CAUSE LOT. USING FIELD DATA THE PERFORMANCE OF LOT 89045M500 WAS EVALUATED. THE INITIAL REACTIVE AND REPEAT REACTIVE RATES OF THE COMPLAINT LOT WERE WITHIN PACKAGE INSERT SPECIFICATIONS. ADDITIONALLY, ASSUMING A ZERO PREVALENCE OF T CRUZI INFECTION FOR THE SAMPLES TESTED THE SPECIFICITY OF LOT 89045M500 WOULD BE WITHIN PACKAGE INSERT SPECIFICATIONS. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE PRISM CHAGAS ASSAY WAS IDENTIFIED.