TRIAGE CARDIAC TRIPLE MARKER PANEL
Received Sep 23, 2015 · Event occurred Aug 25, 2015
Report 2027969-2015-00697 · MDR key 5098209
Device
Product problems
- Device Issue
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: INVESTIGATION PENDING.
Description of Event or Problem
NURSE CALLED ALLEGING DISCREPANT LOW TNI FOR ONE PATIENT. (B)(6) 2015 PATIENT WAS CURRENTLY HOSPITALIZED. DATE OF HOSPITAL ADMISSION, DIAGNOSIS, AND TREATMENT NOT PROVIDED. DURING HOSPITALIZATION, THE FOLLOWING TNI RESULTS WERE OBTAINED. (B)(6) 2015 AT 8:27AM; LAB TNI=0.087; (B)(6) 2015 AT 3:12PM; TRIAGE TNI<0.05; (B)(6) 2015 AT 9:00PM; LAB TNI=0.127 . (B)(4). ALTHOUGH REQUESTED, NO PATIENT OR HOSPITALIZATION DETAILS WERE PROVIDED.
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: RETAIN DEVICES OF CARDIAC LOT W59739RB TESTED WITH THE RETURNED PATIENT SAMPLE BOTH RESULTED IN TNI=<0.05NG/ML. THE BECKMAN ACCESSII ANALYZER RESULTED IN TNI=0.05NG/ML CONFIRMING THE TRIAGE CARDIAC RESULT. RETAINED DEVICES FROM CARDIAC LOT W59739RB WERE PREVIOUSLY TESTED WITH CALIBRATOR J. DATA RESULTS FROM ALL DEVICES YIELDED A CV 8.4% FOR TNI; WITHIN THE PACKAGE INSERT CLAIM. THE PRODUCT PERFORMED AS EXPECTED DURING CALIBRATOR TESTING. REVIEWED THE MANUFACTURING BATCH RECORDS FOR CARDIAC LOT W59739RB. NO ISSUES WITH TNI RECOVERY OBSERVED. NO NCS OR RELEVANT TIFS WERE GENERATED ON THE LOT DURING PRODUCTION. LOT PASSED ALL FINAL RELEASE SPECIFICATIONS. NO PRODUCT DEFICIENCY WAS ESTABLISHED WITH THE TRIAGE CARDIAC DEVICE LOT.