TRIAGE CARDIAC PANEL 25 TEST

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

Description of Event or Problem

REPORTER ALLEGING DISCREPANT LOW TNI RESULT FOR ONE PATIENT. PATIENT VISITED THE HOSPITAL EMERGENCY DEPARTMENT FOR CHEST PAIN. PATIENT ADMITTED TO THE HOSPITAL ON (B)(6) 2015. TRIAGE TNL= <0.05 WB EDTA SAMPLE USED THE SAME DRAW WAS SPUN DOWN TO PLASMA AND RUN ON THE ACCESS2 1-2 HOURS LATER AND ACCESS2=0.13. NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE TRIAGE RESULT. NO MEDICAL INTERVENTIONS GIVEN/PERFORMED BASED ON THE TRIAGE METER RESULT. DATE OF HOSPITAL DISCHARGE NOT PROVIDED. FINAL DISCHARGE DIAGNOSIS ACUTE CORONARY SYNDROME. PATIENT REFERRED TO CARDIOLOGIST. THERE WAS NO TREATMENT GIVEN OR WITHHELD DUE TO TRIAGE METER RESULTS. NO ADDITIONAL PATIENT INFORMATION PROVIDED.

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION UPDATE: RETAIN DEVICES FROM LOT W59245 WERE TESTED WITH CALIBRATOR J; NO DISCREPANT LOW TNI WERE OBSERVED. THE CVS GENERATED FOR TNI WERE AT 9.3% WHICH MEETS THE PI SPECIFICATION OF </= 11.7%. THIS LOT PERFORMED AS EXPECTED. PRODUCT SUPPORT COULD NOT TEST THE RETURNED SAMPLE BECAUSE IT WAS NOT COLLECT IN EDTA TUBE. BATCH RECORDS FOR LOT W59245 WERE REVIEWED AND FOUND NO RELEVANT NCS OR TIFS; THIS LOT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE. PATIENT WAS NOT DIAGNOSED WITH MI, BUT WITH ACUTE CORONARY SYNDROME. NO TREATMENT WAS GIVEN TO PATIENT BASED ON TRIAGE RESULTS.