TRIAGE D-DIMER PANEL

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 (B)(6) 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 (B)(6). 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 (B)(6). OCCURRED ON (B)(6) 2024. CUSTOMER REPORTED DISCREPANT LOW D-DIMER ON TRIAGE D-DIMER VS STAGO FOR 1 PATIENT. SYMPTOMS: ANKLE EDEMA, RIGHT CALF PAIN. DIAGNOSIS: NOT PROVIDED. NO AE OR DEATH REPORTED. PATIENT TREATED WITH: PRIMPÉRAN 10MG/ 2 ML. INEXIUM 40 MG. ACUPAN 20 MG/ 2 ML. GLUCOSE BAXTER 5%.