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

Model Number	INNOVANCE D-DIMER CONTROLS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) technical support technician (tst) analyzed the event to determine the cause of the high, out of range recovery of d-dimer control level 2 on the sysmex ca-1500 system.The tst determined that the quality controls (qc) ranges were incorrectly set on the system.On (b)(6) 2017, the customer calibrated a new reagent lot and started new qc lots.The customer did not update the system's quality control file with the new lots' table of assigned values (tav) ranges.Using the previous lots' tav ranges, the customer ran quality controls and patient samples.The customer ran the patient sample and reported the result when d-dimer control level 2 recovered out of range.As per the tst's instructions, the customer replaced the lamp, recalibrated the assay, corrected the qc ranges and ran the qc, which recovered within expected ranges.The cause of the high, out of range recovery of d-dimer control level 2 is user error.The system is performing according to specifications.No further evaluation of this system is required.Mdr 9610806-2017-00110 was filed for the same event.
Event or Problem Description
A customer reported high, out of range recovery of d-dimer control level 2 on the sysmex ca-1500 system after changing quality control (qc) lots on (b)(6) 2017.D-dimer control qc level 1 was always within the table of assigned values (tav) range.A patient sample was run and the result was reported to the physician while the level 2 qc was out of range.The physician did not question the result.There are no known reports of patient intervention or adverse health consequences due to the potentially discordant d-dimer result.

• Brand Name: INNOVANCE D-DIMER CONTROLS
• Common Device Name: INNOVANCE D-DIMER CONTROLS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 6922082
• Report Number: 9610806-2017-00111
• Device Sequence Number: 13659925
• Product Code: DAP
• UDI-Device Identifier: 00842768023668
• UDI-Public: 00842768023668
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K081732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: 03/21/2019
• Device Model Number: INNOVANCE D-DIMER CONTROLS
• Device Catalogue Number: 10446006
• Device Lot Number: 47454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1