MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PROTEIN C REAGENT; TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Catalog Number	10446185
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 cn-6000 instrument.Siemens is investigating.
Event or Problem Description
The customer reported the observation of a falsely depressed protein c result obtained on one patient sample measured with protein c reagent on the cn-6000 instrument compared to an alternate method.There are no known reports of patient intervention or adverse health consequences due to the discordant results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2025-00054 on 10-dec-2025.Additional information received 19-dec-2025: siemens reviewed the information provided and data obtained.The differences in results likely stem from multiple factors, including variations in methodology, calibration, and reference ranges, which can affect both values and interpretation.For instance, a recent thrombotic event could explain decreased protein c activity, but the original data suggests this alone may not account for the reduction, possibly indicating a deficiency that requires further investigation.Quality control data show all levels within acceptable limits, confirming the instrument is functioning properly.Therefore, the observed differences are most likely due to assay principles (siemens vs.Alternate method) and reagent variability.Based on the available information, a single root cause cannot be definitively assigned.The most plausible explanation remains methodological and reagent differences between the siemens and alternate systems, rather than an analytical error.Assessment of instrument performance included a review of qc (quality control) results have been found within range on the complained day no hardware or software errors could be found in the logs calibration curve was checked, which looks inconspicuous sample results were unflagged.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges.Customer is operational, system works as specified.In section h6, the investigation findings and investigation conclusions codes were updated.The reported behavior was resolved by standard service actions/routine troubleshooting the instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: PROTEIN C REAGENT
• Common Device Name: TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY
• 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: 23766735
• Report Number: 9610806-2025-00054
• Device Sequence Number: 15880527
• Product Code: GGP
• UDI-Device Identifier: 00842768008641
• UDI-Public: (01)00842768008641(10)03234(17)260926
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002541
• 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,Followup
• Report Date (Section B): 01/12/2026

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 Expiration Date: 09/26/2026
• Device Catalogue Number: 10446185
• Device Lot Number: 03234
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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: 58 YR
• Patient Sex: Female