MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE VWF AC; VON WILLEBRAND FACTOR ASSAY

Catalog Number	10487040
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely depressed innovance vwf ac result that was obtained on a patient sample on a bcs xp instrument.Siemens healthineers is investigating.
Event or Problem Description
The customer reported a falsely depressed innovance vwf ac result was obtained on a patient sample on a bcs xp instrument.The erroneous result was reported to the physician(s).The sample was repeated on the same instrument the repeat result was higher than the erroneous result.The repeat 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 discordant, falsely depressed innovance vwf ac result.

• Brand Name: INNOVANCE VWF AC
• Common Device Name: VON WILLEBRAND FACTOR ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer Contact: jana boensch ; emil-von-behring-str. 76; marburg 35041 ; GM 35041 ; 915204870918
• MDR Report Key: 25241346
• Report Number: 9610806-2026-00014
• Device Sequence Number: 9562867
• Product Code: QTY
• UDI-Device Identifier: 00842768028014
• UDI-Public: (01)00842768028014(10)04039(17)271209
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: DEN200067
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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 Catalogue Number: 10487040
• Device Lot Number: 04039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female