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

Model Number INNOVANCE D-DIMER CONTROLS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/11/2017

Event Type  malfunction  

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 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
• Type of Device: INNOVANCE D-DIMER CONTROLS
• 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: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 6922082
• MDR Text Key: 89591923
• Report Number: 9610806-2017-00111
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 00842768023668
• UDI-Public: 00842768023668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/06/2017
• 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