TRIAGE D-DIMER PANEL
Received Jul 10, 2024 · Event occurred May 8, 2024
Report 3013982035-2024-00011 · MDR key 19716622
Device
Generic name
Triage D-dimer Panel
Manufacturer
Quidel Cardiovascular Inc.Model number
98100Lot number
T14826N
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF CORRELATION ISSUES WITH D-DIMER WAS NOT REPLICATED WITH IN-HOUSE RETAIN TESTING OF TRIAGE D-DIMER LOT T14826 WITH AN IN-HOUSE CALIBRATOR. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED, THE LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD FOR TRIAGE D-DIMER LOT T14826. THE LOT MET ALL FINAL RELEASE SPECIFICATIONS. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY OF THIS PRODUCT FOR THE REPORTED FAILURE MODE; NO ISSUES WERE IDENTIFIED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AN NO CORRECTIVE ACTION IS REQUIRED.
Description of Event or Problem
EVENT OCCURRED IN THE USA. OCCURRED ON (B)(6) 2024. CUSTOMER REPORTED POOR TRIAGE D-DIMER CORRELATION WITH SYSMEX CA 660 WITH 3 SAMPLES. NO PATIENT DIAGNOSIS OR OUTCOME PROVIDED. NO AE REPORTED.