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

Catalog Number	10445710
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report discordant increased factor viii (f viii) results obtained on one patient measured with actin fs on the cs-5100 instrument compared to alternate method.Two different samples from the same patient were tested on two dates ((b)(6) 2026).This mdr is about the results obtained on (b)(6) 2026, results obtained on (b)(6) 2026 are referenced in a separate mdr.The available data confirm that the discrepancy is limited to fviii results, while other test results for the same patient were not reported as discrepant.Measurements with factor-deficient plasmas show expected recoveries, and no indication of an inhibitor was reported.Additionally, the patient results show decreased von willebrand factor antigen (vwf ag) and activity (vwf ac), indicating reduced vwf levels.Differences between fviii results obtained with different assay systems may occur due to methodological variability between aptt-based assays, particularly in samples with altered vwf levels.Based on the provided information, there is no indication of an analytical problem specific to the siemens system.The observed discrepancy in fviii results is most likely attributable to method-dependent differences between the assay systems used.No evidence is available suggesting interference from tranexamic acid (exacyl).The 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 discordant increased factor viii (f viii) results obtained on one patient sample measured with actin fs on the cs-5100 instrument compared to alternate method.No result was reported.It is unclear which is the correct result.There are no known reports of patient intervention or adverse health consequences due to the discordant increased f viii results.

• Brand Name: DADE ACTIN FS 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: 25329237
• Report Number: 9610806-2026-00016
• Device Sequence Number: 9954480
• Product Code: GGW
• UDI-Device Identifier: 00842768003844
• UDI-Public: (01)00842768003844(10)562489C(17)270202
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K811589
• 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): 06/03/2026

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: 10445710
• Device Lot Number: 562489C
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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 Age: 17 YR
• Patient Sex: Female