FACTOR VIII CHROMOGENIC ASSAY

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT SHE PIERCED HERSELF IN THE HAND DURING THE PREPARATION OF THE FACTOR X PART OF THE FACTOR VIII CHROMOGENIC ASSAY. PER THE PROCEDURE AT THE CUSTOMER'S SITE, THE FACTOR X REAGENT WAS DISSOLVED BY ADDING WATER USING A SYRINGE WITH AN INJECTION NEEDLE, WHICH WAS PIERCED THROUGH THE CLOSED REAGENT CAP. ACCORDING TO THE FACTOR VIII CHROMOGENIC ASSAY INSTRUCTION FOR USE (IFU), THE FACTOR X REAGENT IS A LYOPHILIZED PREPARATION CONTAINING APPROXIMATELY 2 NMOL OF BOVINE F.X, TRIS-(HYDROXYMETHYL)-AMINOMETHAN (TRIS) BUFFER AT PH 8 AND STABILIZERS. THE CONTENTS OF THE VIAL HAVE TO BE DISSOLVED WITH 2.0 ML OF DISTILLED OR DEIONIZED WATER. HOWEVER, THE CAP OF THE VIAL IS NOT INTENDED TO BE PIERCED THROUGH, BUT RATHER TO BE UNSCREWED AND REMOVED. THE PROCEDURE OF PIERCING THROUGH THE CLOSED REAGENT CAP IS AN OFF-LABEL USE. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT SHE PIERCED HERSELF IN THE HAND DURING THE PREPARATION OF THE FACTOR X PART OF THE FACTOR VIII CHROMOGENIC ASSAY. PER THE PROCEDURE AT THE CUSTOMER SITE, THE FACTOR X REAGENT HAS TO BE DISSOLVED BY ADDING WATER USING A SYRINGE WITH AN INJECTION NEEDLE, WHICH HAS TO BE PIERCED THROUGH THE CLOSED REAGENT CAP. DURING THIS PROCEDURE, THE CUSTOMER PIERCED HERSELF IN THE HAND. THE CUSTOMER WAS WEARING PROTECTIVE GLOVES. THE CUSTOMER WENT TO A MEDICAL DOCTOR, BUT NO MEDICAL TREATMENT WAS REQUIRED. THERE ARE NO KNOWN REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER PIERCING HERSELF IN THE HAND.