TRIAGE CARDIAC TRIPLE MARKER PANEL
Received Nov 22, 2016 · Event occurred Oct 20, 2016
Report 2027969-2016-00692 · MDR key 6122115
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97000HSLot number
W62028B
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- 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
REPORT RECEIVED OF DISCREPANT LOW TNI 2X ON 1 METER/1 LOT. PATIENT #2 TRIAGE=4.11, VISTA DIMENSION=8.09. CONTROLS AND QCD PASS. THREE HOURS BETWEEN CORRELATIONS. REFERENCE RANGE FOR VISTA DIMENSION: 0-0.05. STD DEVIATION FOR VISTA DIMENSION: 0.004; CV=0.05. TESTING FOR TNI ON BOTH INSTRUMENTS . NO SPECIFIC PATIENT INFORMATION PROVIDED. NO REPORTED ADVERSE PATIENT SEQUELA.
Additional Manufacturer Narrative
INVESTIGATION/CONCLUSION: ONE LOW TNI RESULT WAS OBSERVED DURING IN-HOUSE TESTING OF RETAINED DEVICE LOT W62028. ALTHOUGH THE CUSTOMER'S COMPLAINT WAS REPLICATED, THE TNI TOTAL CV WAS FOUND TO BE WITHIN THE PACKAGE INSERT CLAIM. THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. IN-HOUSE TESTING OF THE RETURNED METER DID NOT REPLICATE THE CUSTOMER'S COMPLAINT. NO ISSUES WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W62028 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION WILL NOT BE PURSUED AS THE CUSTOMER'S REPORTED TRIAGE AND REFERENCE RESULTS ALL HAD THE SAME CLINICAL OUTCOME. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.