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

Catalog Number	10445706
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens customer care center to report discordant results that were obtained on one patient sample on the cs-5100 instrument.The following conclusion is made from the troubleshooting performed by siemens healthineers: based on the review of information provided, the probable cause of the discordant high pt.Inr (pt.Sec) results using dade innovin lot 564647 on the cs-5100 system could not be finally identified.However, the elevated result could be caused by an interaction between the multiple medications of this patient affecting the assay.The patient diseases as anti-phospholipid syndrome and dvt (deep vein thrombosis) may affect the pt.Inr values.No other discordant results were obtained; no invalid qcs measurements and no instrument flags have been identified.Reagents are functioning properly.Ultimately, no deficiencies in test performance were identified.The cause of the discrepant results cannot be finally identified.However, possible interference on the patient sample integrity caused by medication and existing illnesses cannot be completely ruled out.The customer is operational.The instrument is performing according to specifications.No further evaluation of this device is required.Note: dade innovin is marketed in the united states under material number 10873566.The 510(k) numbered documented in section g4 is for this product.
Event or Problem Description
The customer reported the observation of discordant increased inr results and falsely elevated pt (prothrombin time) sec results obtained on patient sample measured with dade innovin on the cs-5100 instrument compared to the alternate method.There are no known reports of patient intervention or adverse health consequences due to this 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: monika bornmann ; emil-von-behring str. 76; marburg 35041 ; GM 35041 ; 915121287564
• MDR Report Key: 22083269
• Report Number: 9610806-2025-00018
• Device Sequence Number: 6935396
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: (01)00842768003806(10)564647B(17)260302
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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: 03/02/2026
• Device Catalogue Number: 10445706
• Device Lot Number: 564647B
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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 Sex: Male