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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens regional support center to report a falsely depressed activated partial thromboplastin time (aptt) result measured with the dade® actin® fsl activated ptt reagent on a sysmex cs-2500 system.The result was flagged with two errors that per the cs-2500 instructions for use, instructed the customer to reanalyze the sample.Siemens is investigating.
Event or Problem Description
The customer reported the observation of a falsely depressed activated partial thromboplastin time (aptt) result measured with the dade® actin® fsl activated ptt reagent on a sysmex cs-2500 system.The erroneous result was flagged with two error codes and was reported to the physician(s).The patient was administered 5000 i/u heparin which was later determined to have been unnecessary.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2024-00037 on 23-sep2024.Additional information 20-oct-2024: siemens evaluated this issue and provided the following conclusion: based on review of the data and kinetic analysis, the result was appropriately flagged with 'slight coagulation' and 'coag% changed'.The user disregarded the flags and did not follow the 'corrective actions / counter measures' for the flags as published in the cs-2500 instructions for use manual.Cs-2500 actin fsl lot 562761a is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• 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: jennifer cacace ; 511 benedict ave.; tarrytown, NY 10591 ; 8024302902
• MDR Report Key: 20279006
• Report Number: 9610806-2024-00037
• Device Sequence Number: 7563861
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: (01)00842768003882(10)562761A(17)250809
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K863594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 10/31/2024

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: 08/09/2025
• Device Model Number: N/A
• Device Catalogue Number: 10445714
• Device Lot Number: 562761A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/31/2024
• Date Device Manufactured: 08/10/2023
• 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 Sex: Female