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 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range on the affected sysmex cs-5100 system both before and after the sample was run.While troubleshooting, the customer reverted back to the calibration done on (b)(6) 2023.Four patient samples were run for comparison purposes between the sysmex cs-5100 systems and the results obtained were comparable.A sample specific issue cannot be ruled out as a potential cause of the event as sample quality can change over time.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 sysmex cs-5100 system using the innovance d-dimer reagent.The erroneous result was not reported to the physician(s).The following day, the sample was repeated on an alternate sysmex cs-5100 using the same reagent, recovering higher.The higher result was reported, as the correct result, 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: 17898018
• MDR Text Key: 325370789
• Report Number: 9610806-2023-00017
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445980
• Device Lot Number: 01145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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