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

Model Number	INNOVANCE D-DIMER
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a falsely low d-dimer result was obtained on the sysmex ca-660 system.Siemens reviewed the files that were provided by the customer and determined that there was no indication of an instrument malfunction.The customer indicated that the initial sample was drawn using a becton-dickinson 1.8 ml coagulation tube.The use of this tube type is not supported on the sysmex ca-660 system.The cause of the event is unknown; however, the use of a sample tube that has not been validated by siemens (off-label), inadequate mixing of the sample or other preanalytical variables cannot be ruled out as the cause of the discordant, falsely low d-dimer result.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low d-dimer result was obtained on a (b)(6) female patient using innovance d-dimer kit lot 48736 on a sysmex ca-660 (serial number: (b)(4)) system.The patient underwent a surgery about a week prior to the date of the obtained discordant result and the reason is unknown.The discordant result was obtained using a becton-dickinson (bd) 1.8 ml coagulation tube; the sample was repeated twice with each repeat being flagged by the instrument and non-numerical value obtained.The initial, non-flagged, result was reported to the physician(s) and it was questioned.The patient was redrawn in a bd 2.7 ml coagulation tube for additional repeat testing and the results obtained were higher, which matched the patient clinical history.A corrected reported was issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low d-dimer result obtained on the sysmex ca-660 system.

• Brand Name: INNOVANCE D-DIMER
• Common Device Name: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behringstr. 76; marburg,, D-350 41; GM D-35041
• MDR Report Key: 8651273
• Report Number: 9610806-2019-00050
• Device Sequence Number: 2340382
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: 00842768022814
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 01/14/2020
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445981
• Device Lot Number: 48736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR