TRIAGE D-DIMER PANEL
Received Jun 29, 2016 · Event occurred May 31, 2016
Report 2027969-2016-00476 · MDR key 5759914
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
51 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT OF DISCREPANT HIGH WAS NOT REPLICATED WITH IN-HOUSE CALIBRATOR TESTING AND DONOR WHOLE BLOOD TESTING ON RETAIN LOT W60948. TESTING OF RETURNED SAMPLE REPRODUCED CUSTOMER DISCREPANT HIGH COMPLAINT. ISSUE APPEARS SAMPLE SPECIFIC. REVIEWED THE BATCH RECORD FOR LOT W60948. NO TIFS OR NCS WERE GENERATED DURING MANUFACTURING. LOT MET ALL FINAL RELEASE SPECIFICATIONS. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.
Description of Event or Problem
REPORT RECEIVED OF DISCREPANT HIGH TRIAGE D-DIMER X2 AT 710, 822 NG/ML, ONE PATIENT, FULL DRAW EDTA PLASMA, PATIENT SENT TO HOSPITAL EMERGENCY DEPARTMENT AND TESTED <50 NG/ML. ON (B)(6) 2016: A (B)(6) FEMALE OUT-PATIENT CAME TO THE HOSPITAL COMPLAINING OF FATIGUE, MULTIPLE JOINT PAIN, MEMORY LOSS, HEADACHE, "PRIMARY HYPERCOAGULATION/SECONDARY HYPERCOAGULATION." THE DOCTOR WANTED TO ORDER A "SOLUBLE FIBRIN MONOMER" TEST. WHEN THAT WASN'T FOUND IN THE LIST OF AVAILABLE TESTS, A D-DIMER WAS ORDERED. DISCREPANT HIGH TRIAGE D-DIMER X2 AT 710, 822 NG/ML, ONE PATIENT, FULL DRAW EDTA PLASMA (NO HEMOLYSIS), DLN W60948B. A 710 RESULT OBTAINED ON METER SN (B)(4), 822 RESULT OBTAINED ON METER SN (B)(4). CUSTOMER'S REFERENCE RANGE: 0-600 NG/ML. THE PATIENT WAS SENT TO A LOCAL EMERGENCY DEPARTMENT AND TESTED FOR D-DIMER (TEST UNKNOWN) AT <50 NG/ML. PATIENT WAS DISCHARGED PER CUSTOMER. THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULT.