KIT,TRIAGE, CARDIAC TNI / CKMB

Additional Manufacturer Narrative

D2B PROCODE (CONTINUED): DDR, JHX, MMI. INVESTIGATION IS PENDING.

Description of Event or Problem

THE CUSTOMER REPORTED THREE (3) HIGH CK-MB RESULTS ON A PATIENT. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH BRADYCARDIA AND CHEST PAINS. RESULTS ARE AS FOLLOWS: DATE AND TIME: 07/06/2015 COLLECTED AT 20:00, TRIAGE CK-MB: >80NG/ML AND REPEAT >80NG/ML; DATE AND TIME: 07/07/2015 COLLECTED AT 03:00, TRIAGE CK-MB: 2.2NG/ML AND REPEATED AT 10:00 >80NG/ML; DATE AND TIME: COLLECTED AT 13:00, TRIAGE CK-MB: 1.2NG/ML. ALL TRIAGE TNI RESULTS WERE <0.05NG/ML AND NORMAL TOTAL CK RESULTS. THE TOTAL CK RESULTS ON THE COBAS INTEGRA 400 PLUS ANALYZER WAS 140 ON THE ORIGINAL BLOOD DRAW AND 125 ON THE SECOND BLOOD DRAWN BUT IT WAS HEMOLYZED. THE PATIENT WAS NOT HOSPITALIZED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

INVESTIGATION/CONCLUSION: THE PRODUCT DID NOT RETURN FOR INVESTIGATION. SINCE NO PRODUCT WAS RETURNED, IN HOUSE TESTING WAS PERFORMED WITH RETAIN DEVICES. THERE WERE NO DISCREPANT HIGH CKMB RESULTS OBSERVED ON RETAINED DEVICE TESTED WITH 10 NORMAL WHOLE BLOOD DONOR SAMPLES. A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR CARDIAC LOT W59492RB WAS PERFORMED. THERE WERE NO ISSUES WITH CKMB RECOVERY OBSERVED AND THE LOT PASSED ALL FINAL RELEASE SPECIFICATIONS. TWO (2) PATIENT BLOOD SAMPLES WERE RETURNED FOR TESTING. THE SAMPLES WERE FROM THE SAME PATIENT BUT AT DIFFERENT COLLECTION TIMES. THE CUSTOMER'S COMPLAINT WAS REPLICATED WITH RETURNED PATIENT SAMPLES (ELEVATED CKMB FROM RETURNED SAMPLES ON COMPLAINT LOT). HUMAN ANTI-MOUSE ANTIBODIES (HAMA) INTERFERENCE TESTING WAS CONDUCTED ON THE RETURNED SAMPLE. THE RETURNED SAMPLE CKMB RESULT DECREASED MORE THAN 50% OF ORIGINAL RESULT; SAMPLE CONTAINED HAMA INTERFERENCE. THE ROOT CAUSE FOR THE DISCREPANT HIGH CKMB RESULTS WAS DUE TO THE SAMPLE CONTAINING HAMA INTERFERENCE. AS OF 08/05/2015, THIS IS THE ONLY DISCREPANT HIGH COMPLAINT AGAINST CARDIAC LOT W59492RB. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED AND NO CORRECTIVE ACTION IS REQUIRED.