KIT,TRIAGE, CARDIAC TNI / CKMB

Additional Manufacturer Narrative

D2B PROCODE (CONTINUED): DDR, JHX, MMI THE SECOND STRIP LOT (KIT,TRIAGE, CARDIAC TNI / CKMB, PRODUCT CODE 97022HS; LOT# W59460RB IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER 2027969-2015-00469. INVESTIGATION PENDING.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2015, A (B)(6) FEMALE PRESENTED WITH CHEST PAIN. THE FIRST DRAW AT 1:00 AM WAS TESTED ON A LABORATORY ANALYZER AND THE TROPONIN I (TNI) WAS 0.41. THE PHYSICIAN QUESTIONED THE "POSITIVE TNI" RESULT DUE TO THE AGE OF THE PATIENT, AND ORDERED A TEST BY TRIAGE MONITOR, WHICH IS THEIR BACK-UP METHOD A FEW MINUTES AFTERWARD. THE TRIAGE RESULT FOR TNI WAS < 0.05 (CUT-OFF 0.1), CK-MB WAS < 1.0 USING LOT# W59460RB. THE END-USER WAS LATER INFORMED BY THE PHYSICIAN THAT THIS PATIENT HAD A HISTORY OF MYOCARDITIS AND INDEED HAD AN MYOCARDIAL INFARCTION (MI) THAT CAUSED CHEST-PAIN. THE CURRENT DIAGNOSIS WAS MI AND MYOCARDITIS. THE PATIENT HAS BEEN TRANSFERRED TO ANOTHER HOSPITAL. NO FOLLOW-UP PERFORMED AFTER TRANSFER. END-USER TESTED THE SAME BLOOD SAMPLE ON A DIFFERENT LOT (W59490RB) AND AGAIN AROUND 6:00 AM AND THE TNI WAS < 0.05, CK-MB < 1.0. THERE WAS NO CK-MB RESULT ON THE ANALYZER. NO EKG AND OTHER SUPPORTING TEST REPORT AVAILABLE. NO TREATMENT RECEIVED OR WITHHELD BASED ON TRIAGE RESULT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

INVESTIGATION/CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION AND THE CUSTOMER DID NOT RETURN A SAMPLE FOR ANALYSIS. THE RETAIN STRIP TESTING PERFORMED AS EXPECTED AND THE CUSTOMER'S COMPLAINT FOR DISCREPANT LOW TNI WAS NOT REPLICATED. THE ROOT CAUSE FOR THE DISCREPANT LOW TNI COMPLAINT COULD NOT BE DETERMINED. CUSTOMER DID NOT RETURN SAMPLE;THEREFORE, SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS COULD NOT BE RULED OUT. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.