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

Model Number	FACTOR VIII CHROMOGENIC ASSAY
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).All reaction kinetics were evaluated correctly by the system software.The issue was limited to results for one patient.A sample specific issue related to the patient's treatment cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated factor viii result was obtained on a patient sample on a sysmex cs-5100 system using factor viii chromogenic assay.The discordant result was not reported to the physician(s).A second sample from the same patient that was drawn at the same time was measured for factor viii using a non-siemens assay, recovering lower.It is unknown if this lower result was considered to be correct or if it was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to discordant factor viii result.

• 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-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 14604885
• Report Number: 9610806-2022-00041
• Device Sequence Number: 20002784
• Product Code: GGP
• UDI-Device Identifier: 00842768004032
• UDI-Public: 00842768004032
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K884544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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: 02/21/2023
• Device Model Number: FACTOR VIII CHROMOGENIC ASSAY
• Device Catalogue Number: 10445729
• Device Lot Number: 00199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Sex: Unknown