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	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted siemens customer care center to report falsely elevated aptt (activated partial thromboplastin time) sec results that were obtained on one patient sample on the cs-2500 instrument.The documents provided do not show any analyzer, software, reagent or assay issue. all qc results were found within their ranges on the day the patient sample was measured.The result difference was obvious after re-centrifugation, so most likely refer to sample specific behavior.System works as specified.Customer is operational.The instrument is 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) results obtained on one patient sample measured with dade actin fsl activated ptt reagent on a sysmex cs-2500 system compared to the repeated results.The erroneous result was initially reported to the physician, but corrected by the lower repeated result.There are no known reports of patient intervention or adverse health consequences due to these 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: bernd schick ; emil-von-behring- str. 76; marburg 35041 ; GM 35041 ; 91734802864
• MDR Report Key: 23511209
• Report Number: 9610806-2025-00051
• Device Sequence Number: 13187991
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: (01)00842768003882(10)562798(17)260701
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 11/10/2025

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: 07/01/2026
• Device Catalogue Number: 10445714
• Device Lot Number: 562798
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male