BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACTOR VIII CHROMOGENIC ASSAY

    MDR report key: 8600398 · Received May 10, 2019

    Report

    Report Number
    9610806-2019-00049
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 10, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGP
    UDI-DI
    00842768004032
    PMA / PMN Number
    K884544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395159 FACTOR VIII CHROMOGENIC ASSAY FACTOR VIII CHROMOGENIC ASSAY GGP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH FACTOR VIII CHROMOGENIC ASSAY 48989 00842768004032

    Patients

    Seq Age Sex Outcome Treatment
    1