TRIAGE SOB PANEL

Additional Manufacturer Narrative

INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF DISCREPANT RESULTS/UNSPECIFIED WAS NOT REPLICATED DURING IN-HOUSE RETAIN TESTING OF SOB PANEL LOT T14652 WITH AN IN-HOUSE CALIBRATOR. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED, THE LOT PERFORMED AS EXPECTED. REVIEWED THE BATCH RECORD FOR TRIAGE SOB LOT T14652. 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 GERMANY. CUSTOMER REPORTED DISCREPANT D-DIMER RESULTS ON TRIAGE SOB PANEL VS UNKNOWN LAB METHOD FOR 1 PATIENT. LAB METHOD: UNKNOWN, CUTOFFS: UNKNOWN, SYMPTOMS: UNKNOWN, DIAGNOSIS: UNKNOWN, TREATMENT: UNKNOWN. NO AE OR DEATH REPORTED.