MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT

Model Number	DADE ACTIN FSL ACTIVATED PTT REAGENT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Three falsely elevated factor xi results were obtained on a patient sample on a bcs xp system using dade actin fsl activated ptt reagent.The sample was then repeated three additional times and the results recovered lower.Two days later, a new sample from the patient was collected and was run for factor xi three times, each time recovering falsely elevated.The elevated factor xi result was reported to the physician(s), and the physician(s) questioned the result.Three days later, the sample was rerun for factor xi three times, and recovered lower.There are no known reports of patient intervention or adverse health consequences due to the erroneous factor xi results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The issue was limited to samples from one patient.Fluctuations in factor xi results obtained with different sample dilutions may be caused by a sample specific interferent.The cause of the event is consistent with a sample specific interferent.The reagent is performing according to specifications.No further evaluation of this device is required.A second mdr will be filed for the erroneous results obtained on (b)(6) 2024.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Common Device Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 18730688
• Report Number: 9610806-2024-00002
• Device Sequence Number: 6934033
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (Y/N): N
• 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): 02/19/2024

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: 11/08/2024
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 562731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female