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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.No mechanical issues were observed, and all reaction kinetics were correctly evaluated by the system software.Pre-analytical issues such as not properly mixing the patient sample may have contributed to the discordant results.The cause of the event is unknown.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 international normalized ratio (inr) result was obtained on a patient sample on a sysmex cs-2100i system using thromborel s reagent.Due to the high result, the sample was rerun for inr using the same system and same reagent, resulting lower.The same sample was then repeated for inr on a sysmex cs-5100 system using thromborel s reagent, resulting lower.The initial discordant result obtained on the sysmex cs-2100i system was auto-validated and reported to the physician(s).The customer informed the physician(s) to disregard the falsely elevated inr result and requested that another sample from the patient be obtained and run for inr.The patient was redrawn and the sample was run for inr, resulting lower and matching the result previously obtained on the sysmex cs-5100 system.This 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 international normalized ratio (inr) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2020-00048 on 24-sep-2020.Additional information (28-sep-2020): section d8 of the mdr was changed from "unknown" to "no".Correction (30-sep-2020): section b6 of the mdr was changed to indicate the prothrombin time international normalized ratio (inr) result of 2.19 was also considered to be discordant.

• 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: 10580966
• Report Number: 9610806-2020-00048
• Device Sequence Number: 304808
• 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
• Serviced by Third Party (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): 10/20/2020

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: 05/06/2021
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 565677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR