• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE VON WILLEBRAND FACTOR ACTIVITY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE VON WILLEBRAND FACTOR ACTIVITY Back to Search Results
Model Number INNOVANCE VON WILLEBRAND FACTOR ACTIVITY
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2022
Event Type  malfunction  
Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).No hardware error messages occurred during the time of the event.No sample or reagent handling errors were identified.No issues were observed with the sample kinetics.Interference due to human anti-mouse antibodies (hama) cannot be ruled out as a potential cause of the inconsistent results.As per the innovance von willebrand factor activity instructions for use (ifu): "patient samples may contain heterophilic antibodies (e.G.Human anti-mouse antibodies (hama) and rheumatoid factors) or paraproteins that could react in turbidimetric assays using mouse monoclonal antibodies to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies by addition of a blocking reagent.No interference of rheumatoid factors (rf) was observed up to 940 iu/ml.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed." additionally the ifu indicates: "results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings." the cause of the event is unknown.The atellica coag 360 system is not marketed in the us nor similar in design to a siemens product registered in the us.The reagent is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2022-00057 and 9610806-2022-00059 were filed for the discordant results obtained on (b)(6) 2022 and (b)(6) 2022, respectively.
 
Event Description
A falsely low von willebrand factor activity (vwf ac) result was obtained on a patient sample on an atellica coag 360 system using innovance von willebrand factor activity reagent.The discordant result was not reported to the physician(s).Three days later the sample was repeated for vwf ac four times, two times using the vwf ac low setting and two times using the vwf ac medium setting.The results obtained using the vwf ac medium setting recovered falsely low.The sample was frozen and was rerun for vwf ac eighteen days later using both the vwf ac low setting and the vwf ac medium setting.The result obtained using the vwf ac medium setting recovered falsely low.After diluting the sample 1:2 and running the sample, a correct numeric vwf ac result was obtained using the vwf low setting.There are no known reports of patient intervention or adverse health consequences due to falsely low vwf ac results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INNOVANCE VON WILLEBRAND FACTOR ACTIVITY
Type of Device
INNOVANCE VON WILLEBRAND FACTOR ACTIVITY
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 Key16067758
MDR Text Key308527780
Report Number9610806-2022-00058
Device Sequence Number1
Product Code GGP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/29/2022
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
Device Operator Health Professional
Device Expiration Date05/24/2024
Device Model NumberINNOVANCE VON WILLEBRAND FACTOR ACTIVITY
Device Catalogue Number10487040
Device Lot Number01298
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2022
Initial Date FDA Received12/29/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-