TRIAGE D-DIMER PANEL
Received Feb 18, 2016 · Event occurred Jan 21, 2016
Report 2027969-2016-00099 · MDR key 5445530
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
98100EULot number
W60288RB
Product problems
- False Negative Result
- False Negative Result
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 D-DIMER WAS NOT REPLICATED WITH IN-HOUSE TESTING ON RETAIN LOT W60288. LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD FOR LOT W60288. LOT MET ALL OUS FINAL RELEASE SPECIFICATIONS. NO SAMPLE WAS RETURNED, UNABLE TO DETERMINE ROOT CAUSE OF CUSTOMERS DISCREPANCY. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. AS OF 2/8/2016, THIS IS THE ONLY COMPLAINT OF DISCREPANT LOW AGAINST LOT W60288.
Description of Event or Problem
EVENT OCCURRED IN (B)(6). REPORT RECEIVED OF TRIAGE FALSE NEGATIVE RESULTS FOR TRIAGE D-DIMER PANEL. NO CONFIRMATORY RESULTS WERE REPORTED. D-DIMER RESULT REPORTED TO BE 302. REPORTEDLY, PATIENT DIAGNOSED WITH VTE/DVT (CONFIRMATORY METHOD UNKNOWN) AND WAS REFERRED TO HOSPITAL. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION PROVIDED. NO REPORTED ADVERSE PATIENT SEQUELA.