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

Model Number INNOVANCE D-DIMER

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2020

Event Type  malfunction  

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 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
• 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 ; 9145242740
• MDR Report Key: 9672841
• MDR Text Key: 191035898
• Report Number: 9610806-2020-00004
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 00842768022821
• UDI-Public: 00842768022821
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2018
• 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