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	10/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The twelve discordant results were obtained after the customer loaded a new reagent vial of thromborel s onto the sysmex cs-5100 system.The customer did not rerun quality controls (qc) after loading the new reagent vial.The issue was resolved after replacing the reagent vial the following day.As per the instructions for use (ifu) for thromborel s, "two levels of quality control material (normal and pathological range) have to be measured at start of the test run, with each calibration, upon reagent vial changes and at least every eight hours on each day of testing.The control material should be processed as a sample.If control values are recovered outside the defined range, check the instrument, reagent and calibration for problems.Do not release patient results until the cause of deviation has been identified and corrected." the customer did not follow these instructions in the ifu after loading the new reagent vial.The cause of the event is use error.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2021-00067 was filed for the discordant results obtained on (b)(6) 2021.
Event or Problem Description
Twelve discordant, falsely elevated prothrombin time (pt) results were obtained on patient samples on a sysmex cs-5100 system using thromborel s reagent.The elevated pt results were reported to the physician(s) and were questioned.The following day, the patient samples were rerun for pt, recovering lower.The lower results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated prothrombin time 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: 12751524
• Report Number: 9610806-2021-00068
• Device Sequence Number: 17283271
• 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
• Report Date (Section B): 11/04/2021

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: 04/15/2023
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 568022A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1