MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

Model Number	BCS XP SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Two falsely low von willebrand factor activity (vwf ac) results were obtained on one patient sample on a bcs xp system using bc von willebrand reagent.The results were reported to the physician(s) and were questioned.The following day the same sample was repeated for vwf ac on an alternate bcs xp system, recovering higher.The higher result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low vwf ac results.
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.No instrument errors occurred at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse changed the mixing frequency for the bc von willebrand factor reagent from 10 minutes to 3 minutes.Siemens is investigating the issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2023-00004 on 10-feb-2023.Additional information (21-feb-2023): quality controls (qc) recovered in range at the time of the event.No issues were noted with other patient samples, indicating that the instrument and reagents were performing acceptably.Sample integrity issues and preanalytical variables potentially contributed to the falsely low von willebrand factor activity results.The investigation findings and investigation conclusion codes in section h6 were updated to reflect the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: BCS XP SYSTEM
• Common Device Name: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16358337
• Report Number: 9610806-2023-00004
• Device Sequence Number: 6318912
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K970431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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 Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/16/2023
• 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 Sex: Unknown