TRIAGE CARDIAC TRIPLE MARKER PANEL
Received Sep 19, 2016 · Event occurred Sep 6, 2016
Report 2027969-2016-00627 · MDR key 5960303
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97000HSLot number
W61684B
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT OF DISCREPANT LOW WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W61684. ONE RESULT WAS LOW OUTSIDE THE 2SD RANGE BUT WITHIN 3SD. NO SAMPLE WAS RETURNED TO PRODUCT SUPPORT, FURTHER INVESTIGATION CANNOT BE PURSUED. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. REVIEWED THE BATCH RECORD FOR LOT W61684. LOT MET ALL FINAL RELEASE SPECIFICATIONS. UNABLE TO DETERMINE ROOT CAUSE OF COMPLAINT. NO PRODUCT DEFICIENCY WAS ESTABLISHED.
Description of Event or Problem
CUSTOMER STATES SHE IS PERFORMING A CORRELATION STUDY BETWEEN THE TRIAGE METER AND VITROS 5600 ANALYZER FOR TNI ON FIVE DIFFERENT SAMPLES. ALL FIVE SAMPLES GAVE NORMAL RESULTS ON THE TRIAGE METER BUT ABNORMAL RESULTS ON THE VITROS ANALYZER. CUSTOMER ONLY ABLE TO PROVIDE EXACT RESULTS ON SAMPLE #5. SAMPLE#5: TRIAGE=0.07, 0.10; VITROS 5600=0.549. NO REPORTED TREATMENT ORDERED OR WITHHELD RELATED TO TRIAGE RESULTS. THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULT. NO PATIENT INFORMATION PROVIDED.