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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report the observation of falsely depressed fibrinogen results on one patient measured with the dade thrombin reagent on a sysmex cs-5100 system compared to the historical fibrinogen results obtained on an alternate method.The instrument generated a flag and did not display numerical results, and the user ignored or misinterpreted the message or flag and reported numerical results.The instrument performed as expected.Per the limitations section of the dade thrombin reagent instructions for use (ifu): "results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings." siemens is investigating.
Event or Problem Description
The customer reported the observation of falsely depressed fibrinogen results on one patient measured with the siemens dade thrombin reagent on a sysmex cs-5100 system (legal manufacturer: sysmex) compared to the historical fibrinogen results obtained on an alternate method.The patient sample was processed in 1:1 and 4:1 dilutions.For both dilution results, the instrument generated a flag and did not display numerical results.However, the user ignored or misinterpreted the message or flag and reported the results (as <0.3 g/l) to the physician(s), who questioned the results.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed fibrinogen results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2024-00021 on 25-jul-2024.Additional information 01-aug-2024: overall siemens could not identify a clear result discordance in the patient sample recovery for the complained sample using the sysmex cs-5100 system with dade thrombin reagent.The discordant results observed by the customer were tested in may 2024 and june 2024, and only one valid result was obtained (0.33 g/l for the 4:1 dilution, other results generated a flag and did not display numerical results).The historical results on the alternate method which the customer considered correct were tested from february 2023 to november 2023, and results ranged from 0.5 to 0.8 g/l on the alternate method during this timeframe.No direct comparison of a patient result is given as there are several months between the sysmex cs-5100 system results and the alternate method results.There are many reasons which might interfere on the patient.A certain deviation between to different testing systems must be expected depending on the technique, method, equipment and reagent lot used.Reagent issues were ruled out based on review of quality control (qc), which showed recovery within acceptable ranges, and no issues were reported with other patient samples.Based on the available information, the cause of the discordant result is inconclusive.The customer is operational, and the reported issue is resolved by routine troubleshooting.Siemens has no indication on a potential performance issue with neither instrument nor reagent.The dade thrombin reagent is performing as intended.A product performance issue has not been identified.

• 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: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 19826720
• Report Number: 9610806-2024-00021
• Device Sequence Number: 8679553
• Product Code: KQJ
• UDI-Device Identifier: 00842768003950
• UDI-Public: (01)00842768003950(10)567436(17)20251004
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: 10/04/2025
• Device Model Number: N/A
• Device Catalogue Number: 10445721
• Device Lot Number: 567436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• 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: Unknown