TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

Description of Event or Problem

THE CUSTOMER CALLED AND ALLEGED A POTENTIAL FALSE POSITIVE TRIAGE TROPONIN (TNI) RESULT IN COMPARISON TO A NEGATIVE TNI ON THE VITROS LABORATORY ANALYZER. ON (B)(6) 2015, THE PATIENT PRESENTED TO URGENT CARE FOR CHEST PAIN. AT 15:57, THE TRIAGE TNI WAS 0.10 AND THE VITROS TNI WAS 0.01. THE CUT-OFF FOR TRIAGE WAS 0.05 - 0.4 "CRITICAL" AND > 0.4 "HIGH CRITICAL." THE CUT-OFF FOR THE VITRO WAS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE RESULT WAS NEGATIVE. THE ELECTROCARDIOGRAM (EKG) SHOWED ABNORMAL T-WAVE AND S-T SEGMENT BUT NO SPECIFICS WAS PROVIDED. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. THE SECOND TNI WAS PERFORMED AT 21:00 ON THE VITROS ANALYZER AND WAS 0.01. THERE WAS NO TRIAGE TNI PERFORMED ON THE SECOND DRAW. THE CUSTOMER HAS NO ACCESS TO THE PATIENT'S INFORMATION SINCE THE TRANSFER TO (B)(6) HOSPITAL. THERE WAS NO INVASIVE PROCEDURE PERFORMED OR ANY HARM TO THE PATIENT WHILE AT THE URGENT CARE BASED ON THE TRIAGE RESULT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

PRO CODES: DDR, JHX, MMI. INVESTIGATION PENDING.

Additional Manufacturer Narrative

INVESTIGATION/CONCLUSION: THE DEVICE DID NOT RETURN FOR EVALUATION. THE CUSTOMER'S COMPLAINT OF DISCREPANT TROPONIN WAS NOT REPLICATED WITH IN-HOUSE TESTING. LOT W59216 PERFORMED AS EXPECTED. CUSTOMER RAN ONLY ONE TEST WITH THE TRAIGE CARDIAC DEVICE; DID NOT TEST A SECOND TRIAGE DEVICE FOR CONFIRMATION. NO SAMPLE WAS RETURNED; THEREFORE SAMPLE SPECIFIC INTERFERENCE IS UNABLE TO RULED OUT AS A POTENTIAL CAUSE OF THE COMPLAINT. REVIEW OF THE BATCH RECORDS FOUND NO NON-CONFORMANCES. THE CUSTOMER'S COMPLAINT OF DISCREPANT HIGH TNI WAS NOT OBSERVED. THERE IS ONLY ONE COMPLAINT FOR CARDIAC LOT W59216. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.