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

Model Number INNOVANCE D-DIMER

Device Problem Low Test Results (2458)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality control (qc) information was not provided by the customer.The sample results were evaluated correctly by the system.The samples were analyzed over multiple days, and a sample related issue cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

A falsely low d-dimer result was obtained on a patient sample on a sysmex cs-2500 system using innovance d-dimer reagent.The result was not reported to the physician(s) as the d-dimer result obtained from the patient five days prior had been elevated.The sample was repeated three times for d-dimer the following day using the same system and reagent, recovering higher.The higher results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low d-dimer result.

• 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: 15820745
• MDR Text Key: 305514666
• Report Number: 9610806-2022-00054
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2023
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445979
• Device Lot Number: 00623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/17/2022
• 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: Reuse
• Patient Sequence Number: 1