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	10/30/2019
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 backup files from the sysmex cs-5100 system were sent to siemens for further evaluation.Siemens is investigating the issue.
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 when run with dade innovin reagent.An additional discordant, falsely elevated pt result, an additional discordant, falsely elevated inr result, and an additional discordant, falsely low pt% result were obtained when the same patient sample was rerun on an alternate sysmex cs-5100 system using thromborel s reagent.The following day, a new sample was collected from the patient and was run for pt, inr, and pt% using dade innovin reagent.The pt and inr resulted lower and the pt% resulted higher.This inr result obtained with the dade innovin reagent was reported, as the corrected 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.
Additional Manufacturer Narrative
Additional information (11-nov-2019): quality controls (qc) recovered within specifications at the time of the event.All reaction kinetics were correctly evaluated by the system software.No system or software issue could be identified.The cause of the event was not established.A possible cause of the event is a pre-analytical or sample specific issue.The reagent is performing according to specifications.No further evaluation of this device is required.

• 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: 9370271
• Report Number: 9610806-2019-00088
• Device Sequence Number: 14130423
• 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,Followup
• Report Date (Section B): 12/27/2019

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
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR