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

Model Number	THROMBOREL S
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Siemens determined that pre-analytical issues (specific sample characteristics, blood collection, transportation, and/or sample processing/handling in the laboratory) potentially contributed to the discordant results.Siemens specialists were previously dispatched to the customer's site to evaluate and discuss pre-analytical handling conditions with the customer.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) and prothrombin time international normalized ratio (inr) result, as well as a discordant, falsely low prothrombin time percent (pt%) result were obtained on a patient sample on a sysmex cs-5100 system (serial number: (b)(4)) using thromborel s reagent.Prior to obtaining the discordant results, the sample was run for inr using dade innovin reagent on two different sysmex cs-5100 systems (serial numbers: (b)(4)) but the systems did not yield numeric results and generated no coagulation errors.After the initial discordant results were obtained using thromborel s reagent, the sample was repeated for inr on sysmex cs-5100 system (serial number: (b)(4)) using dade innovin reagent but the system did not yield numeric results and generated no coagulation errors.The sample was then repeated for pt, inr, and pt% on sysmex cs-5100 system (serial number: (b)(4)) using thromborel s reagent.The pt and inr recovered falsely high, and the pt% recovered falsely low.None of the discordant results were reported to the physician(s).The following day, a new sample from the same patient was run was for pt, inr, and pt% on sysmex cs-5100 system (serial number: (b)(4)) using dade innovin reagent.The pt and inr recovered lower and the pt% recovered higher.This inr result 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) and 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: 10061296
• Report Number: 9610806-2020-00021
• Device Sequence Number: 2400724
• 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): 05/15/2020

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: 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: 04/20/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR