PRISM CHAGAS
Received Aug 28, 2018
Report 1415939-2018-00122 · MDR key 7824143
Device
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING, REVIEW OF FIELD DATA REACTIVE RATES, AND A SENSITIVITY AND SPECIFICITY REVIEW. NO ADVERSE TREND WAS IDENTIFIED FOR THE ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BOTH SPECIFICITY AND SENSITIVITY REVIEWS MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Description of Event or Problem
DURING A CLINICAL EVALUATION STUDY USING PRISM CHAGAS AS THE PREDICATE PRODUCT, A DONOR SPECIMEN TESTED ON PRISM WAS FOUND TO BE DISCORDANT RELATIVE TO ANOTHER SUPPLEMENTAL METHOD BEING USED FOR FINAL RESULT INTERPRETATION. TWO FALSE NON-REACTIVE SAMPLES ON THE PRISM CHAGAS ASSAY FOR SAMPLES W14091712737300 AND W14091801031634 WERE IDENTIFIED DURING THE COURSE OF THE STUDY. THE DONOR WAS DEFERRED AND THE BLOOD PRODUCT WAS DESTROYED; THERE WAS NO IMPACT TO PATIENT MANAGEMENT.