TRIAGE D-DIMER PANEL

Additional Manufacturer Narrative

D2B PROCODE (CONTINUED): DAP. THE TRIAGE D-DIMER TEST (98100EU, LOT# W58797RB) REFERENCED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER (2027969-2015-00902). INVESTIGATION/CONCLUSION: ALL DATA RESULTS FROM D-DIMER LOTS (W59959RB AND W58797RB) TESTED WITH IN-HOUSE CALIBRATOR WERE WITHIN THE EXPECTED VALUE AND THE PERCENT OF COEFFICIENT OF VARIATIONS WERE WITHIN THE OUS FINAL RELEASE TESTING SPECIFICATIONS. THE MANUFACTURING BATCH RECORDS FOR D-DIMER LOTS (W59959RB AND W58797RB) WERE REVIEWED AND THE LOTS PASSED OUS FINAL RELEASE SPECIFICATIONS. SINCE NO SAMPLE WAS RETURNED, SAMPLE SPECIFIC INTERFERENCE COULD NOT BE RULED OUT AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED. 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 ALERE (B)(4) AFFILIATE HAD NOT BEEN ESCALATED TO ALERE (B)(4) (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 AA, HAD A TRIAGE D-DIMER RESULT CLOSE TO 300 NG/ML WHILE THE VIDAS LABORATORY ANALYZER RESULT WAS CLOSE TO 650 NG/ML. THE CUSTOMER REPORTED TWO (2) LOT NUMBERS (W58797RB AND W59959RB) BUT COULD NOT IDENTIFY WHICH LOT NUMBER THE TRIAGE D-DIMER RESULT WAS FROM. 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.)