KIT,TRIAGE, CARDIAC TNI / CKMB

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

Description of Event or Problem

REPORT CALLER ALLEGING DISCREPANT FN TNL VS. BECKMAN ACCESS. PATIENT PRESENTED WITH CHEST AND STOMACH PAIN/CRAMPING; SOB; PALPITATIONS. PATIENT HAS A HISTORY OF HIGH BLOOD PRESSURE, BUT PATIENT OFF MEDICATIONS. BP: 186/127. ADMINISTERED NITROGLYCERIN WHICH HELPED THE PATIENT. DOPPLER WAS NORMAL. DOCTOR NOTED THAT LIVE FAILURE COULD HAVE CAUSED THE ELEVATED TNI. (B)(6) 2015 AT 8:55 P.M.: TRIAGE METER #(B)(4); LOT #W59737; WB EDTA RESULTED TNI <0.05; CK-MB 1.4. (B)(6) 2015 AT 9:54 P.M.: TRIAGE METER #(B)(4); LOT #W59737: WB EDTA RESULTED TNI <0.05; CK-MB <1.0. BECKMAN ACCESS; LI PLASMA SAMPLE: (B)(6) 2015 AT 4:47 A.M. RESULTED TNI 0.14; CK-MB 1.4. (B)(6) 2015 AT 1:15 P.M. RESULTED TNI 0.13; CK-MB 1.6. (B)(6) 2015 AT 8:48 P.M. RESULTED TNI 0.14; CK-MB 1.6. TRIAGE METER RANGE: TNI (0-0.1); CK-MB (0-4.3). BECKMAN RANGE: TNI (0-0.1); CK-MB (0-3.9). ADMINISTERED FIVE EKGS TO PATIENT AND REFERRED FOR CONSULT WITH CARDIOLOGY. NO EKG RESULTS PROVIDED. PATIENT DISCHARGED (B)(6) 2015 TO HOME HEALTH. NO ADVERSE EVENTS REPORTED RELATED TO THE TRIAGE RESULT. NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION UPDATE: AFTER INVESTIGATION, NO DISCREPANT TNI RESULTS WERE OBSERVED WITH IN-HOUSE TESTING OF RETAIN LOT W59737RB. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. THE PRODUCT PERFORMED AS EXPECTED. CUSTOMER DID NOT RETURN ANY SAMPLE; UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE OF THE COMPLAINT. BATCH RECORDS FOR LOT W59737RB WERE REVIEWED AND FOUND NO RELEVANT NCS AND/OR TIFS. THIS PRODUCT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE. CUSTOMER DID NOT RUN SAMPLES SIDE BY SIDE ON BOTH ANALYZERS, WHICH MAY CAUSE DISCREPANT RESULTS BETWEEN THE ANALYZERS. AS OF 8/3/15, THERE HAVE BEEN ONLY 2 DISCREPANT COMPLAINTS FOR CARDIAC LOT W59737RB. NO PRODUCT DEFICIENCY WAS ESTABLISHED.