MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE THROMBIN REAGENT; SYSTEM, FIBRINOGEN DETERMINATION

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	09/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens regional support center to report non-numeric, flagged, patient results measured with the dade thrombin reagent on a sysmex cs-2500 instrument.The results were flagged with errors and 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 non-numeric, flagged, patient results measured with the dade thrombin reagent on a sysmex cs-2500 instrument.The customer used the calibration curve to estimate a result of 2.14 g/l and this was reported to, and not questioned by, the physician(s).
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2024-000469610806-2024-00046 on 23-oct-2024.Additional information 04-nov-2024: siemens evaluated this issue and provided the following conclusion: based on a review of the information provided, this issue was caused by a user handling error.The device properly displayed flag '0008.0032.0000 coagulation curve error: fbg curve error' yet the user disregarded the error and manually calculated an estimated fbg result.Cs-2500 dade thrombin reagent lot 567430a is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.

• Brand Name: DADE THROMBIN REAGENT
• Common Device Name: SYSTEM, FIBRINOGEN DETERMINATION
• 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: 20513198
• Report Number: 9610806-2024-00046
• Device Sequence Number: 7044921
• Product Code: KQJ
• UDI-Device Identifier: 00842768003943
• UDI-Public: (01)00842768003943(10)567430A(17)250723
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 07/23/2025
• Device Model Number: N/A
• Device Catalogue Number: 10445720
• Device Lot Number: 567430A
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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: Male