MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN; TEST, TIME, PROTHROMBIN

Catalog Number	10873567
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An united states (ous) customer contacted siemens customer care center to report discordant pt (inr, sec) results that were obtained on a patient sample on the cs-2500 system compared to repeat the testing on the cs-5100 system.Siemens healthineers reviewed and investigated the information provided.There is no evidence of any analyzer, software, reagent or assay issue.The kinetics are characteristic of a sample that was not mixed properly after blood draw.This indicates the issue is a pre-analytical issue with the sample.System works as specified.Customer is operational.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported the observation that the inr and the associated pt.Sec determinations of a patient sample performed with dade innovin on cs-2500 s/n (b)(6) were falsely elevated compared to repeat testing on cs-5100 s/n (b)(6) and the clinical picture.There are no known reports of patient intervention or adverse health consequences due to the discordant results.

• Brand Name: DADE INNOVIN
• Common Device Name: TEST, TIME, PROTHROMBIN
• 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: bernd schick ; emil-von-behring- str. 76; marburg 35041 ; GM 35041 ; 91734802864
• MDR Report Key: 23920619
• Report Number: 9610806-2025-00057
• Device Sequence Number: 9296207
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: (01)00630414023489(10)564671(17)270926
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• 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
• Report Date (Section B): 12/30/2025

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 Catalogue Number: 10873567
• Device Lot Number: 564671
• 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: 12/16/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown