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
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
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.The following conclusion is made from the troubleshooting performed by siemens healthineers: the patient is heterozygous for factor v leiden (fvl).This genotype causes apc (activated protein c) resistance and leads to method-specific interference in the siemens clot-based protein c assay, resulting in falsely low activity values.Because the siemens protein c reagent depends on apc-mediated prolongation of clotting time, patients with fvl/apc resistance can appear to have reduced protein c activity according to the limitations section of the instruction for use (ifu) of protein c, ¿the presence of a mutation of factor v at the protein ca cleavage site (factor v leiden) may likewise lead to diminished recovery of protein c 6,7.¿ in contrast, the used alternate method is less affected by apc resistance, which explains the normal result obtained there.No other discordant results were obtained; no invalid quality controls 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 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.

• 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: 23715281
• Report Number: 9610806-2025-00053
• Device Sequence Number: 8845466
• 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
• Report Date (Section B): 12/04/2025

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: 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: 11/18/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 31 YR
• Patient Sex: Female