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

Model Number INNOVANCE D-DIMER

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 310795820
• Report Number: 9610806-2023-00005
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: 00842768022814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male