inforMED
MalfunctionGHH

TRIAGE D-DIMER PANEL

Received Aug 25, 2025

Report 3013982035-2025-00022 · MDR key 22889708

Device

Generic name

Triage D-dimer Panel

Model number

98100EU

Lot number

T15202RBN

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

Description of Event or Problem

EVENT OCCURRED IN COLOMBIA. EVENT 2: CUSTOMER REPORTED D-DIMER DISCREPANCIES ON SAMPLE (B)(6) WHILE RUNNING A CORRELATION ON TRIAGE D-DIMER LOT T15202 (326; CUTOFF: <500 NG/ML) VS WERFEN ACLTOP 300 (538; CUTOFF: 499.9 NG/ML), FINAL DIAGNOSIS: EMBOLISM AND THROMBOSIS IN OTHER VEINS. NO AE REPORTED.

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF DISCREPANT LOW ISSUES WITH D-DIMER WAS NOT REPLICATED WITH IN-HOUSE RETAIN TESTING OF TRIAGE D-DIMER LOT T15202 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 T15202. 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.