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

Model Number	INNOVANCE D-DIMER
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center to report that their innovance d-dimer controls were out of range.It was found that the customer had not calibrated the current lot of innovance d-dimer reagent.Patient results had been reported out after the lot had been changed and prior to the controls being found out of range.After the controls were found to be out of range, all samples were run on an alternate system.The customer was instructed on how to perform the calibration and how to set the system parameters to reflect the current innovance d-dimer kit lot number being used.Based on the information provided, use error is probable cause for not calibrating the d-dimer assay for innovance d-dimer kit lot 48985.The customer did not follow the recommendations in the ca-1500 innovance d-dimer application sheet which states a new standard curve must be established when changing a reagent lot.Control recovery in range using calibration curve for kit lot number 48985 indicates that both the instrument and reagents were performing as expected.Customer is operational and no product problem was identified.The cause of the innovance d-dimer controls being out of range is due to use error.The reagent and instrument are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that their innovance d-dimer controls were out of range.It was determined that the customer had not calibrated the innovance d-dimer reagent for their current reagent kit lot number 48985.Both the reagent and control lots were incorrect in the analyzer settings.The customer could not provide the date when the current lots were put into use.Patient results were reported after the assay lot was changed and prior to the controls being found to be out of range, however none of the results were questioned or reported as discordant.After the controls were found to be out of range there were no patient results reported.Patient samples were run on an alternate system at this time.There are no reports of patient intervention or adverse health consequences due to the innovance d-dimer controls being out of range.

• 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
• MDR Report Key: 9672841
• Report Number: 9610806-2020-00004
• Device Sequence Number: 2884526
• Product Code: DAP
• UDI-Device Identifier: 00842768022821
• UDI-Public: 00842768022821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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: 08/19/2020
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445982
• Device Lot Number: 48985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1