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

Catalog Number	10445729
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, high factor viii patient result on the bcs xp system.No product non-conformance could be identified and all information that was provided indicates a possible sample specific issue.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, high factor viii patient result (chromogenic factor viii assay) was generated on the bcs xp system compared to a chromogenic factor viii assay patient result generated at another reference lab (esoterix).A different patient sample (from the same patient) was used at esoterix, but it is not known what system was used.Factor viii activity was also high on that patient sample on the bcs xp system compared to the factor viii activity result generated at the reference lab (esoterix).Quality controls were in range.There are no reports of patient intervention or adverse health consequence due to the discordant, high factor viii patient 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 strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 7053625
• Report Number: 9610806-2017-00134
• Device Sequence Number: 86157
• Product Code: GGP
• UDI-Device Identifier: 00842768004032
• UDI-Public: 00842768004032
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K884544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 02/07/2018
• Device Catalogue Number: 10445729
• Device Lot Number: 529391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR