MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT; TEST, TIME, PARTIAL THROMBOPLASTIN

Catalog Number	10445714
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An united states (us) customer contacted siemens customer care center to report a falsely elevated aptt (activated partial thromboplastin time) sec result that was 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 falsely elevated aptt results using dade actin fsl activated ptt reagent on the cs-5100 system could not be identified.Service engineer checked customer system, system is operational and working acceptable.The customer is operational.Assay and instrument are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported the observation of a falsely elevated aptt (activated partial thromboplastin time) sec result obtained on a patient sample measured with dade actin fsl activated ptt reagent on the cs-5100 instrument, compared to repeat result.The falsely elevated result was reported to the physician who did not question the result.The lab autoverified the result and provided a corrected report.There are no known reports of patient intervention or adverse health consequences due to this discordant results.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Common Device Name: TEST, TIME, PARTIAL THROMBOPLASTIN
• 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: sandra dastig ; emil-von-behring- str. 76; marburg 35041 ; GM 35041 ; 91729477610
• MDR Report Key: 23036672
• Report Number: 9610806-2025-00045
• Device Sequence Number: 18562458
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: (01)00842768003882(10)575026(17)261217
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K863594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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 Catalogue Number: 10445714
• Device Lot Number: 575026
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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: 72 YR
• Patient Sex: Female