TRIAGE CARDIAC PANEL 25 TEST

Description of Event or Problem

THE CUSTOMER CALLED AND ALLEGED A POTENTIAL (B)(6) TRIAGE TROPONIN (TNI) RESULT AND CREATINE KINASE-MYOCARDIAL BAND (CK-MB) IN COMPARISON TO A POSITIVE TNI AND CK-MB ON THE SIEMENS EXL LABORATORY ANALYZER. (B)(6). THE ELECTROCARDIOGRAM (EKG), OBTAINED AT ADMISSION AND SUBSEQUENT EKG WERE NORMAL. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. THERE WAS NO REPORTED INVASIVE PROCEDURE PERFORMED OR ANY HARM TO THE PATIENT BASED ON THE TRIAGE RESULTS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PATIENT WAS DIAGNOSED WITH RHABDOMYOLYSIS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

INVESTIGATION/CONCLUSION: THE CUSTOMER'S COMPLAINT OF FALSE NEGATIVE/DISCREPANT LOW TNI AND CK-MB WAS NOT OBSERVED WITH IN-HOUSE TESTING ON RETAIN LOT W59043B. TESTING MET SPECIFICATIONS VALUES THAT ARE WITHIN THE PACKAGE INSERT CLAIM AND THE LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD OF LOT W59043B FOUND NO NON-CONFORMANCES OR TESTING INVESTIGATION FORMS GENERATED DURING PRODUCTION OF THE LOT. THE CUSTOMER DID NOT SEND A SAMPLE FOR TESTING SINCE THE ELECTROCARDIOGRAM (EKG) WAS NEGATIVE AND THE PATIENT WAS DIAGNOSED WITH RHABDOMYOLYSIS; THEREFORE, FURTHER INVESTIGATION CANNOT BE PURSUED TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR THE REPORTED DISCREPANT RESULTS. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED AND NO CORRECTIVE ACTION IS REQUIRED.

Additional Manufacturer Narrative

(B)(4). INVESTIGATION PENDING.