TRIAGE PROFILER SOB PANEL (25T) 25 TEST

Additional Manufacturer Narrative

PRODUCT CODES CONTINUED: NBC, DAP, DDR, JHX, MMI. INVESTIGATION CONCLUSION: THERE WERE NO DISCREPANT LOW TNI RESULTS OBSERVED FROM ANY RETAIN DEVICES TESTED WITH AN IN-HOUSE CALIBRATOR. THE COEFFICIENT OF VARIATION WAS WITHIN THE PRODUCT INSERT CLAIM. THE MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. SINCE NO SAMPLE WAS RETURNED, SAMPLE SPECIFIC INTERFERENCE WAS UNABLE TO BE RULED OUT AS A POTENTIAL CAUSE FOR THE DISCREPANT RESULTS. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED AND NO CORRECTIVE ACTION IS REQUIRED.

Description of Event or Problem

ON (B)(6) 2015 AN EMAIL NOTIFICATION WAS RECEIVED FROM THE ALERE ACCOUNT MANAGER REGARDING A POTENTIAL FALSE NEGATIVE TRIAGE TROPONIN TNI (TNI) WHICH OCCURRED IN (B)(6). ON THE MORNING OF (B)(6) 2015, THE PATIENT PRESENTED TO THE MEDICAL CLINIC. THE PATIENT WAS QUITE UNWELL WITH CHEST PAIN AND HAD BEEN UNWELL THE NIGHT BEFORE. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED WHICH SHOWED THE HEART RATE TO BE 140 AND ST SEGMENT DEPRESSION. THE TRIAGE TNI RESULT WAS <0.05 NG/ML (THE CUSTOMER SET CUT-OFF OF 0.40 CONSIDERED NEGATIVE), D-DIMER 305, MYO 27.4 (THE CUSTOMER SET CUT-OFF OF 107 CONSIDERED NEGATIVE), BNP 121 (THE CUSTOMER SET CUT-OFF OF 100 CONSIDERED NEGATIVE), CKMB 3.5. AT THE SAME TIME, BLOOD SAMPLES WERE OBTAINED AND SENT TO (B)(6). FROM THOSE SAMPLES, THE ABBOTT I-STAT ANALYZER RESULT WAS 0.13 UG/L (THE CUSTOMER SET CUT-OFF 0.10 OR GREATER IS CONSIDERED POSITIVE). THE I-STAT RESULT WAS OBTAINED FROM (B)(6). THE PATIENT WAS TRANSFERRED FROM THE MEDICAL CLINIC IN (B)(6) TO (B)(6) IN (B)(6). IN THE AFTERNOON AT 15:35, A BLOOD SAMPLE WAS COLLECTED AND SENT TO (B)(6). THE TNI RESULT WAS REPORTED AS 9.15UG/L. THE PATIENT PASSED AWAY LATER THAT NIGHT ((B)(6) 2015). ALTHOUGH REQUESTED, THE MEDICAL CLINIC WHERE THE PATIENT FIRST PRESENTED IS UNABLE TO OBTAIN THE CAUSE OF DEATH, DUE TO THE (B)(6) PRIVACY ACT. THE NURSE AT THE CLINIC VERBALLY STATED TO ALERE TECHNICAL SUPPORT THAT SHE DID NOT BELIEVE THAT THEIR TREATMENT OF THE PATIENT WAS IMPACTED BY THE TRIAGE RESULT. ( NOTE: THE TRIAGE PROFILER SOB PANEL DEVICE IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, THIS MDR FILING IS DUE TO A SAME OR SIMILAR DEVICE AVAILABLE IN THE UNITED STATES).