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	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens customer care center to report discordant pt.Inr results that were obtained on 4 different patient sample on the cs-2500 instrument.The information provided did not show any analyzer and/or software issues.Based on the available information, the probable cause of the discordant result is consistent with a reagent related issue which could not be clearly identified due to limited qc testing.System works as specified.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.
Event or Problem Description
The customer reported the observation of falsely elevated pt (prothrombin time) inr (international normalized ratio) results obtained on four (4) patient samples measured with thromborel s on the cs-2500 instrument.The erroneous results were reported to the physician(s) but they were not questioned.The samples were repeated on the same instrument.The repeat results were lower than the erroneous results.The repeated results were reported, as the correct results, to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant pt inr results.

• 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- str. 76; marburg 35041 ; GM 35041 ; 91734802864
• MDR Report Key: 24387180
• Report Number: 9610806-2026-00005
• Device Sequence Number: 10567738
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: (01)00842768011337(10)576519(17)270424
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 02/19/2026

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: 10446445
• Device Lot Number: 576519
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• 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: Unknown