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

Catalog Number 10445729

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2017

Event Type  malfunction  

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 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
• Type of Device: FACTOR VIII CHROMOGENIC ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• Manufacturer Contact: loriann russo ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242287
• MDR Report Key: 7053625
• MDR Text Key: 93433487
• Report Number: 9610806-2017-00134
• Device Sequence Number: 1
• Product Code: GGP
• UDI-Device Identifier: 00842768004032
• UDI-Public: 00842768004032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2018
• Device Catalogue Number: 10445729
• Device Lot Number: 529391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 51 YR