MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE D-DIMER; FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Catalog Number	10445981
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the observation of a discordant negative d-dimer patient sample result obtained on patient sample measured with innovance d-dimer on ca-660 instrument compared to repeat testing.The discordant negative result was not reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant result.
Additional Manufacturer Narrative
An united states (us) customer contacted a siemens customer care center to report the observation of a false negative d-dimer result on a ca-660 instrument.Service went on site and checked and verified led detector, performed all mechanical alignments, detector, adjusted temperature.Instrument is fully operational.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Customer is operational after routine troubleshooting.A product issue was not identified.

• Brand Name: INNOVANCE D-DIMER
• Common Device Name: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL
• 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: 22355954
• Report Number: 9610806-2025-00024
• Device Sequence Number: 8759413
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: (01)00842768022814(10)02308(17)251119
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K093626
• 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): 06/30/2025

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: 11/19/2025
• Device Catalogue Number: 10445981
• Device Lot Number: 02308
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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 Age: 42 YR
• Patient Sex: Female