MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH FACTOR VIII CHROMOGENIC ASSAY

Model Number	FACTOR VIII CHROMOGENIC ASSAY
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: FACTOR VIII CHROMOGENIC ASSAY
• Common Device Name: FACTOR VIII CHROMOGENIC ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg d-35041, ; GM
• MDR Report Key: 8600398
• Report Number: 9610806-2019-00049
• Device Sequence Number: 2180881
• Product Code: GGP
• UDI-Device Identifier: 00842768004032
• UDI-Public: 00842768004032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K884544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: FACTOR VIII CHROMOGENIC ASSAY
• Device Catalogue Number: 10445729
• Device Lot Number: 48989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1