MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH THROMBOREL S

Model Number	THROMBOREL S
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Siemens reviewed the back-up files that were provided by the customer and determined there was no indication of a system nor reagent malfunction.All controls are in range on the day of the event.Maintenance was performed regularly.All inspected kinetics were evaluated correctly by the system software.The cause of the discordant, falsely low pt, inr and falsely elevated prothrombin time (pt) pt% results was due to a pre-activation issue.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely low prothrombin time (pt), falsely low inr (international normalized ratio) and falsely elevated pt % results were obtained on a patient sample using thromborels (lot 562877) on a sysmex cs-5100 system.The discordant results were reported to a physician(s), who questioned the results.The patient was redrawn and a new sample was tested on an alternate sysmex cs-5100 system using the same reagent and resulting higher for pt, inr and lower for pt %.The result obtained on the new sample was reported to the physician.The initial sample was repeated on the initial sysmex cs-5100 system and the result correlated with the new sample results.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low pt, inr and falsely elevated pt % result.

• Brand Name: THROMBOREL S
• Common Device Name: THROMBOREL S
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8334848
• Report Number: 9610806-2019-00010
• Device Sequence Number: 1578140
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: 00842768011337
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 02/13/2019

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: 01/05/2020
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 562877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR