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

Model Number INNOVANCE D-DIMER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The "measurement error" obtained on the initial result indicates that analysis failed due to insufficient volume of plasma or an error of the instrument.The corrective action is to prepare a required volume of plasma and perform reanalysis, but the customer misinterpreted this result as a high d-dimer result and therefore ran the ddi+ application.The sample should have been initially repeated using the ddi application, not the ddi+ application.The following two results were flagged as "<" because the sample did not need these actions performed, and the result was within the calibration curve.The cause of the event is use error.Siemens is investigating the issue.

Event Description

A discordant, falsely elevated d-dimer result was obtained on a patient sample on a sysmex ca-660 system using innovance d-dimer reagent.The sample was repeated for d-dimer using the d-dimer+ (ddi+) application with the same system and reagent, also recovering falsely elevated.The sample was then repeated a third time for d-dimer using a 1:4 dilution with the same system and reagent, recovering falsely low.The sample was then repeated two more times for d-dimer using the same system and reagent.Both of these results were considered to be correct, and the second of the two results was reported to the physician(s).The sample was then repeated one final time using the same system but a different reagent lot.This result was also considered to be correct.There are no reports of patient intervention or adverse health consequences due to the discordant d-dimer results.

• 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: 11406808
• MDR Text Key: 244407692
• Report Number: 9610806-2021-00023
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2021

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: 08/11/2021
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445979
• Device Lot Number: 49881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/03/2021
• 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