KIT, TRIAGE, CARDIAC TNI/CKMB

Additional Manufacturer Narrative

NO SAMPLE WAS RETURNED TO PRODUCT SUPPORT, FURTHER INVESTIGATION CANNOT BE PURSUED. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. REVIEWED THE BATCH RECORD FOR LOT W61171. LOT MET ALL CARDIAC TNI/CKMB FINAL RELEASE SPECIFICATIONS. TRIAGE CARDIAC TNI/CKMB IS NOT CLAIMED TO CORRELATE WITH BECKMAN DXI ANALYZER. UNABLE TO DETERMINE ROOT CAUSE OF COMPLAINT. NO PRODUCT DEFICIENCY WAS ESTABLISHED.

Description of Event or Problem

EMAIL RECEIVED. CUSTOMER ALLEGING CRITICALLY HIGHER TNI ON TRIAGE CARDIAC TNI/CKMB IN THE EMERGENCY ROOM THAN THE HOSPITAL RETEST. REPORT OF A TROPONIN RESULT ON THE TRIAGE METER THAT WAS GREATER THAN 7.0. TRIAGE RESULTS WERE 7.27 NG/ML CKMB WAS 14.4 NG/ML PATIENT ADMITTED TO EMERGENCY ROOM FOR SOB, CHEST PAIN, CHILLS, FEVER, LETHARGY AND WAS IMMEDIATELY TRANSFERRED TO HOSPITAL ICU BASED ON EXTREMELY HIGH TROPONIN, D-DIMER, BNP LAB RESULTS AND PATIENT'S GENERAL CONDITION. THE PATIENT WAS SENT TO A HOSPITAL ICU AND RERAN THE TROPONIN. REPORTEDLY A RETEST IN THE HOSPITAL ICU ON THE BECKMAN DXI HAD NORMAL RESULTS. NO VALUES WERE REPORTED ONLY THAT THE RESULTS WERE IN THE NORMAL RANGE. WHEN THE PATIENT ARRIVED TO THE HOSPITAL, THEY PERFORMED THEIR OWN LABS AND FOUND THE TROPONIN AND CKMB TO BE NORMAL. NO SPECIFIC VALUES REPORTED. THE PATIENT STAYED DUE TO OTHER CO-MORBIDITIES BUT NOT ELEVATED ENZYMES RELATED. DATES OF HOSPITAL STAY NOT PROVIDED. DIAGNOSIS NOT PROVIDED. NO MEDICAL INTERVENTIONS WERE REPORTED BASED ON THE TRIAGE RESULT. CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.