TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

Additional Manufacturer Narrative

PRODUCT CODE (CONTINUED): DDR, JHX AND MMI. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY FOR LOT W60030RB WAS PERFORMED AND NO DISCREPANCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. SINCE NO SAMPLE WAS RETURNED, SAMPLE SPECIFIC INTERFERENCE IS UNABLE TO BE RULED OUT AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. BASED ON THE INFORMATION AVAILABLE, THE PRODUCT PERFORMED AS EXPECTED. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED A VARIANCE BETWEEN THE TRIAGE TROPONIN (TNI) RESULT AND THE LABORATORY TNI RESULT. ON (B)(6) 2015, A (B)(6) FEMALE PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE TRIAGE TNI RESULT WAS 0.27 AT 12:14 AND THE LABORATORY TNI WAS <0.03 AT 13:00. BOTH RESULTS WERE FROM THE SAME SAMPLE DRAW. THE CUSTOMER HAD NO CONCERNS ABOUT SAMPLE QUALITY AS IT WAS CHECKED FOR HEMOLYSIS, CLOTS, LIPEMIA, ETC. ELECTROCARDIOGRAM (EKG) WAS PERFORMED BUT THE RESULT WAS NOT AVAILABLE PER CUSTOMER. ADDITIONAL LABORATORY TESTING AS FOLLOWS: (B)(6). THERE WERE NO INVASIVE PROCEDURES PERFORMED AND THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH THE FOLLOWING DIAGNOSIS: CHEST WALL MUSCLE SPASM, HYPERTENSION, TOBACCO USE AND URINARY TRACT INFECTION (UTI).