MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH THROMBOREL S; TEST, TIME, PROTHROMBIN

Catalog Number	10446445
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
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 thromborel s on the cs-2500 instrument.There are no known reports of patient intervention or adverse health consequences due to this discordant results.
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-2500 instrument.The description of the issue indicates that the sample was lipemic.It is possible that the affected sample was not mixed accordingly after blood draw.A software, assay or system issue was not identified.Customer is operational.The instrument is performing according to specifications.No further evaluation of this device is required.Note: thromborel s is marketed in the united states under material number 10873565.The 510(k) numbered documented in section g4 is for this product.

• Brand Name: THROMBOREL S
• 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 strasse 76; marburg 35041 ; GM 35041 ; 91734802864
• MDR Report Key: 22317866
• Report Number: 9610806-2025-00022
• Device Sequence Number: 15690344
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: (01)00842768011337(10)572137A(17)260222
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003870
• 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): 06/24/2025

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: 02/22/2026
• Device Catalogue Number: 10446445
• Device Lot Number: 572137A
• 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: 06/06/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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: 56 YR
• Patient Sex: Male