INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF RETAIN LOT W63726RB WITH WHOLE BLOOD DONORS AND IN-HOUSE SAMPLES. TESTING FOUND NO ISSUES WITH PRODUCT PERFORMANCE; NO DISCORDANT CKMB RESULTS WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W63726RB WERE REVIEWED AND FOUND THAT THE LOT MET FINAL RELEASE SPECIFICATIONS. NO ISSUES WITH CKMB RECOVERY OBSERVED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, PATIENT SAMPLE WAS RETURNED. OBSERVED ELEVATED CKMB RESULTS WITH THE RETURNED PATIENT SAMPLE. HAMA INTERFERENCE TESTING WAS INCONCLUSIVE. THE RETURNED PATIENT SAMPLE WAS OBSERVED TO BE SEVERELY HEMOLYZED. ALTHOUGH HAMA INTERFERENCE TESTING WAS INCONCLUSIVE, ADDITIONAL SAMPLE SPECIFIC FACTORS/INTERFERENCE IN THE RETURNED SAMPLE CANNOT BE RULED OUT AS THE CAUSE OF THE COMPLAINT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THIS EVENT IS RELATED TO MDR 3013982035-2018-00010.
D
Patient 1
CUSTOMER REPORTED DISCORDANT RESULTS FOR CKMB ON TRIAGE COMPARED TO THE BECKMAN DXI ANALYZER. ON (B)(6) 2018, PATIENT PRESENTED TO THE URGENT ROOM FOR DIZZINESS. PATIENT SAMPLE WAS RUN ON AN ALTERNATE TRIAGE LOT NUMBER AND RESULTED WITH AN ELEVATED CKMB RESULT. MDR 3013982035-2018-00010 CAPTURES THIS EVENT. THE PATIENT SAMPLE WAS TESTED ON THE BECKMAN DXI ANALYZER WITH A CKMB RESULT OF 3.8 NG/ML. SAMPLE WAS REPEATED ON THE DXI AND YIELDED CKMB RESULT OF 4.0 NG/ML. CUSTOMER PROVIDED THE DXI CUT-OFF OF 6.4 NG/ML. THE PATIENT SAMPLE WAS RETESTED 3 DAYS LATER ON TRIAGE LOT NUMBER W63726RB AND YIELDED A CKMB RESULT OF 38.9 NG/ML (SIMILAR TO THE ORIGINAL TRIAGE RESULT). CUSTOMER STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. CUSTOMER STATED NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON TRIAGE RESULT AND THAT THE PATIENT ENCOUNTERED NO HARM. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CKMB RESULT.