TRIAGE PROFILER SOB PANEL

Additional Manufacturer Narrative

(B)(4). INVESTIGATION/CONCLUSION: THE CUSTOMER DID NOT PROVIDE A LOT NUMBER OR RETURN ANY PRODUCTS FOR INVESTIGATION. SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER PRODUCT INVESTIGATION WAS NOT POSSIBLE. FURTHER INVESTIGATION PERFORMED UNDER INTERNAL CAPA-(B)(4) RELATED TO LATE REGULATORY ESCALATION.

Description of Event or Problem

THIS EVENT WAS IDENTIFIED AS PART OF AN EVALUATION IN WHICH COMPLAINTS REPORTED TO (B)(6) AFFILIATE HAD NOT BEEN ESCALATED TO ALERE SAN DIEGO (ASD) FOR REGULATORY REVIEW AND INVESTIGATION. THERE IS LIMITED INFORMATION AVAILABLE REGARDING THE EVENT AND DUE TO THE TIME GAP BETWEEN WHEN THE COMPLAINT WAS FIRST REPORTED TO WHEN ASD WAS NOTIFIED, ADDITIONAL INFORMATION IS NOT AVAILABLE. THE EVENT OCCURRED IN THE (B)(6). THE CUSTOMER REPORTED THAT THE PATIENT, IDENTIFIED AS (B)(6), PRESENTED TO THE EMERGENCY ROOM WITH ATYPICAL CHEST PAIN. TRIAGE TEST AT 1255 SHOWED THE FOLLOWING RESULTS: CKMB=10.2 NG/ML, TNI <0.05 NG/ML, MYO >500 NG/ML, D-DIMER < 100NG/ML, BNP=16 PG/ML. AT 1408 LABORATORY RESULTS WERE AS FOLLOWS: CK=0.6 NG/ML, TNI <0.01 UG/ML AND MYO=36.0 NG/ML. DUE TO DIVERGENCES, THE TRIAGE TESTS WERE REPEATED AT 1500, WITH THE FOLLOWING RESULTS: CKMB <1.0 NG/ML, TNI <0.05 NG/ML, MYO=35.1 NG/ML, D-DIMER <100 NG/ML AND BNP=21.3 PG/ML. ON (B)(6) 2015, NO CHANGES IN THE LABORATORY TESTS FOR CARDIAC ENZYMES. THE PATIENT WAS ADMITTED FOR INVESTIGATION OF CHEST PAIN. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)