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

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	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens customer care center (ccc) to report discordant d-dimer results that were obtained on a patient sample on a sysmex cs-2500 system.Quality controls (qcs) recovered within ranges on the day of the event.Per the limitations section of the innovance® d-dimer 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.Dvt clinical diagnosis should not be based on the result of innovance® d-dimer alone." siemens investigated the issue.Upon review of this event and available data, it was concluded that routine troubleshooting resolved the issue and product problem was not confirmed.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.It was confirmed that the official assay protocol had been used for innovance d-dimer.Siemens checked the calibration curve and sample kinetic data and did not identify any issues.Based on the available information, the cause of the discordant result may be due to heterophilic antibodies in the patient sample.The customer is operational, and the reported issue is resolved by routine troubleshooting.The innovance d-dimer lot 02427 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.
Event or Problem Description
The customer reported the observation of discordant d-dimer results for one patient measured neat (1:1) and diluted (1:10) with the innovance d-dimer reagent on a sysmex cs-2500 system.The erroneous result from the diluted sample was reported to the physician(s), who did not question the result.The same sample was repeated neat and diluted (1:1, 1:10 automatic dilution, and 1:2 manual dilution) and results were still discordant.A new sample was collected from the patient and was repeated (neat) on the same instrument and at another lab on another sysmex cs-2500 system.The result from the other lab was considered correct and reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant d-dimer results.

• 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: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 20608708
• Report Number: 9610806-2024-00048
• Device Sequence Number: 7411250
• Product Code: DAP
• UDI-Device Identifier: 00842768022821
• UDI-Public: (01)00842768022821(10)02427(17)260128
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/05/2024

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: 01/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 10445982
• Device Lot Number: 02427
• 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: 10/22/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: 57 YR
• Patient Sex: Female