TRIAGE CARDIAC PANEL 25 TEST
Received May 22, 2015 · Event occurred Apr 28, 2015
Report 2027969-2015-00364 · MDR key 4792782
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97000HSLot number
W59043B
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CALLED AND ALLEGED A POTENTIAL LOW TRIAGE TROPONIN (TNI) RESULT IN COMPARISON TO THE VITROS LABORATORY ANALYZER RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, DEVICE: TRIAGE, TNI: <0.05. (B)(6) 2015, VITROS, 1.4. EDTA AND SERUM TUBE WAS DRAWN WITHIN 5 MINUTES OF EACH OTHER. THE VITROS CRITICAL VALUE >0.1. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE PATIENT OR TESTING.
Additional Manufacturer Narrative
INVESTIGATION/CONCLUSION:THE CUSTOMER'S COMPLAINT OF DISCREPANT LOW TNI WAS NOT OBSERVED WITH IN-HOUSE TESTING ON RETAIN LOT W59043B. TESTING MET SPECIFICATIONS VALUES THAT ARE WITHIN THE PACKAGE INSERT CLAIM AND THE LOT PERFORMED AS EXPECTED.REVIEWED THE BATCH RECORD OF LOT W59043B FOUND NO NON-CONFORMANCES OR TESTING INVESTIGATION FORMS GENERATED DURING PRODUCTION OF THE LOT. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED AND NO CORRECTIVE ACTION IS REQUIRED.
Additional Manufacturer Narrative
(B)(4). INVESTIGATION PENDING.