TRIAGE PROFILER SOB PANEL

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: NO DISCREPANT LOW RESULTS WERE OBSERVED FROM ANY DEVICES TESTED WITH CAL H. DATA RESULTS FROM ALL DEVICES TESTED WITH CAL H WERE WITHIN 2SD OF THE EXPECTED VALUE AND A CV OF 5.58% IS WITHIN MANUFACTURING FINAL RELEASE SPECIFICATIONS. REVIEWED THE MANUFACTURING BATCH RECORDS FOR SOB LOT W59664. NO ISSUES WITH D-DIMER RECOVERY OBSERVED. NO NCS OR TIFS WERE GENERATED ON THE LOT DURING PRODUCTION. LOT PASSED ALL FINAL RELEASE SPECIFICATIONS. AS OF (B)(6) 2015, THIS IS THE ONLY DISCREPANT LOW COMPLAINT AGAINST SOB LOT W59664. NO SAMPLE WAS RETURNED. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. NO PRODUCT DEFICIENCY WAS ESTABLISHED WITH THE TRIAGE SOB DEVICE LOT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem

DISCREPANT SOB PROFILER RESULTS. EVENT OCCURRED IN (B)(6). PATIENT CAME TO PHYSICIAN'S OFFICE WITH ACUTE DEEP VEIN THROMBOSIS. DOCTOR GAVE HEPARIN AND SENT PATIENT TO CARDIOLOGIST. CARDIOLOGIST MEASURED A DDIMER OF 250 WITH SOB PROFILER. SECOND MEASUREMENT 260 NG/ML. TIME BETWEEN MEASUREMENTS NOT REPORTED. THROMBOSIS WAS VERIFIED BY ULTRASOUND. NO MEDICATION OF THE PATIENT. PATIENT WAS ASKED TO RETURN TO PHYSICIAN'S OFFICE IN 3 MONTH. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION PROVIDED. NO REPORTED ADVERSE EVENTS.