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

Model Number	THROMBOREL S
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely elevated prothrombin time (pt) result, a discordant, falsely elevated prothrombin time international normalized ratio (inr) result, and a discordant, falsely low prothrombin time percent (pt%) result were obtained on a patient sample on a sysmex cs-5100 system using thromborel s reagent.The customer provided siemens with the system reaction kinetics.All reaction kinetics were evaluated correctly by the system software.The reason for the drift downwards in seconds is a gradient in the patient sample caused by nonmixing of the primary tube after the blood was drawn.The second patient sample is consistent in all measurements, showing that the issue is sample specific.Mdr 9610806-2019-00084 was also filed for the discordant results for the same patient obtained with dade innovin reagent.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) result, a discordant, falsely elevated prothrombin time international normalized ratio (inr) result, and a discordant, falsely low prothrombin time percent (pt%) result were obtained on a patient sample on a sysmex cs-5100 system using thromborel s reagent.Prior to obtaining these discordant results, the initial inr results for this sample had no coagulation error flags.An additional discordant falsely elevated prothrombin time (pt) result, two discordant, falsely elevated prothrombin time international normalized ratio (inr) results, and one discordant, falsely low prothrombin time percent (pt%) result were obtained on the same patient sample when the sample was rerun on an alternate sysmex cs-5100 system using dade innovin reagent.The same sample was then repeated for pt, inr, and pt% on the same alternate system with thromborel s reagent.The pt and inr resulted lower and the pt% resulted higher.The same sample was then repeated for pt, inr, and pt% on the same alternate system using dade innovin reagent.The pt and inr resulted lower and the pt% resulted higher than the initial discordant results.The same sample was repeated again for pt, inr, and pt% on the same alternate system with thromborel s reagent.The pt and inr resulted lower and the pt% resulted higher than the initial discordant results.A new sample from the same patient was then run twice for pt, inr, and pt% on the same alternate system using dade innovin reagent.The pt and inr resulted lower and the pt% resulted higher than the initial discordant results.The last inr result obtained was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) results, the discordant, falsely elevated prothrombin time international normalized ratio (inr) results, or the discordant, falsely low prothrombin time percent (pt%) results.

• 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: 9316297
• Report Number: 9610806-2019-00083
• Device Sequence Number: 2360820
• 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): 11/13/2019

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: 10/18/2020
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 565636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR