MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH THROMBOREL-S10XF.10ML

Model Number	THROMBOREL-S10XF.10ML
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discordant, falsely low prothrombin time international normalized ratio (inr) result was obtained on a sysmex cs-5100 system using the thromborel-s reagent.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely low prothrombin time international normalized ratio (inr) result was obtained on a sysmex cs-5100 system using the thromborel-s reagent.The discordant result was reported to the physician(s).The physician(s) questioned the reported result.The following day, the physician(s) performed a point of care finger prick test and got a higher result.Also the following day, the original patient sample was repeated on the same sysmex cs-5100 system resulting higher.The original sample was then tested on an alternate sysmex cs-2100 system which also resulted higher.The higher results were considered as correct and a corrected report was submitted to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low prothrombin time international normalized ratio result on the sysmex cs-5100 system.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2020-00001 on 06-jan-2020.Additional information (20-jan-2020): siemens investigated the provided customer backup data.All reaction kinetics were evaluated correctly by the system software.The affected visible kinetics are showing significant artifacts which are leading to error flags.Reasons for that can be an aspiration of reagent sediment possibly due to the customer transferring the extra volume of empty thromborel s reagent vials.This action may increase the amount of sediment in the reagent vials and, therefore, increase the risk for aspiration of sediment.Also a weak mixing of the reconstituted thromborel s reagent can lead to a higher amount of sediment.No system or software issue could be identified.System works as specified.The cause of the discordant, falsely depressed prothrombin time international normalized ratio (inr) result obtained on a sysmex cs-5100 system using the thromborel-s reagent is unknown.Customer is operational.Section h6 was updated to reflect this additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: THROMBOREL-S10XF.10ML
• Common Device Name: THROMBOREL-S10XF.10ML
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 9554135
• Report Number: 9610806-2020-00001
• Device Sequence Number: 3461896
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: 00842768011337
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 02/05/2020
• Device Model Number: THROMBOREL-S10XF.10ML
• Device Catalogue Number: 10446445
• Device Lot Number: 562880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR