MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE D-DIMER

Model Number	INNOVANCE D-DIMER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that a physician misinterpreted an innovance d-dimer result of 0.93 mcg/ml with a reference range of 0.19 to 1.12 mcg/ml from the sysmex cs-2500 system as a result within the normal range, instead of above the cut-off for the exclusion of venous thromboembolism (vte).As a result, the physician(s) sent the patient home without further testing.After realizing the misinterpretation, the physician(s) re-evaluated the case and determined that the patient was not at risk of vte.This report is being filed in an abundance of caution.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The customer informed siemens that they updated their reference range to be 0.19 to - 0.49 mg/l to utilize the cut-off when assessing for venous thromboembolism (vte).Siemens evaluated the innovance d-dimer instructions for use (ifu) and sysmex automated blood coagulation analyzer cs-2500 reference guide and determined that the labeling regarding the cut-off value for the exclusion of vte using the innovance d-dimer is not misleading.The following sections demonstrates the assay was evaluated to validate the exclusion of dvt: "clinical performance of the innovance d-dimer assay to exclude dvt" in the innovance d-dimer ifu and "clinical performance" in the sysmex automated blood coagulation analyzer cs-2500 reference guide.Both document indicates patient specimens were tested with the innovance d-dimer assay and results were compared to a cut-off value of 0.50 mg/l (feu).A d-dimer result < 0.50 mg/l (feu) was considered negative and a d-dimer result >= 0.50 mg/l (feu) was considered positive.The cause of the event is use error and this report is being filed in an abundance of caution as there is no evidence of an instrument nor reagent malfunction.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: INNOVANCE D-DIMER
• Common Device Name: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16460696
• Report Number: 9610806-2023-00005
• Device Sequence Number: 14051798
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: 00842768022814
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 03/01/2023

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: 12/12/2023
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445981
• Device Lot Number: 01105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Male