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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a flagged aptt (activated partial thromboplastin time) result obtained on a patient sample on cs-2500 instrument.Based on the review of information provided, no clot formation took place within the whole measurement time even up to 360 sec.The drift of the baseline is unspecific.The sample was correctly flagged.Quality controls (qcs) recovered within ranges on the day of the event.The flagged result could be caused by ldl in combination with a high crp or propofol treatment.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 a flagged aptt (activated partial thromboplastin time) result obtained on a patient sample on cs-2500 instrument.The flagged result was reported to the physician.The physician questioned the patient result, and the laboratory repeated the measurement on an alternate instrument.The repeat result was longer than the erroneous reported result.The repeat result was reported, as the correct result, to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneous reported aptt result.

• 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: 25180610
• Report Number: 9610806-2026-00012
• Device Sequence Number: 13345563
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: (01)00842768003882(10)562798(17)260701
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/15/2026

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: 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: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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: 39 YR
• Patient Sex: Female