MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE VWF AC

Model Number	INNOVANCE VWF AC
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) reporting non-reproducible elevated von willebrand factor activity (vwf ac) results.A patient specific issue caused by hama interference has not been ruled out as a potential cause of the event.Siemens is investigating the issue.A second mdr will be filed for the erroneous result obtained on 27-aug-2024.
Event or Problem Description
A customer reported the observation of a falsely elevated von willebrand factor activity (vwf ac) result was obtained on a patient sample on a bcs xp system using innovance vwf ac reagent.The erroneous result was not reported to the physician(s).Two days later, the sample was repeated three times for vwf ac using the same reagent on an alternate bcs xp system.Two of the three results recovered falsely elevated and the first result recovered lower.The lower result was considered to be the correct result for the patient.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated vwf ac results.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 22-oct-2024.Additional information (13-dec-2024): quality controls (qc) recovered in range at the time of the event.A reagent issue was ruled out as a cause of the event.The cause of the event is consistent with a sample specific interferent, most likely caused by hama interference.As per the instructions for use (ifu) for innovance® vwf ac, under limitations: "patient samples may contain heterophile antibodies [e.G.Human anti-mouse antibodies (hamas) or rheumatoid factors] that could react in antibody using assays to give a falsely elevated (observed more often) or depressed result.This assay has been designed to minimize interference from heterophile antibodies by addition of a blocking reagent.Nevertheless, complete elimination of such an interference from all patient specimens cannot be guaranteed.The diagnosis or exclusion of any type of vwd should therefore never be based solely on the innovance® vwf ac result." the reagent is performing according to specifications.No further evaluation of this device is required.The investigation findings and investigation findings codes in section h6 were updated based on the additional information.Mdr 9610806-2024-00044 was filed for the erroneous result obtained on 27-aug-2024.Supplemental mdr 9610806-2024-00044_s1 was also filed for the additional information.

• Brand Name: INNOVANCE VWF AC
• Common Device Name: INNOVANCE VWF AC
• 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: 20508117
• Report Number: 9610806-2024-00045
• Device Sequence Number: 18122738
• Product Code: QTY
• UDI-Device Identifier: 00842768028014
• UDI-Public: (01)00842768028014(10)02596(17)260414
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 04/14/2026
• Device Model Number: INNOVANCE VWF AC
• Device Catalogue Number: 10487040
• Device Lot Number: 02596
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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: 57 YR
• Patient Sex: Female