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	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center.Siemens investigated the system files provided by the customer and did not find any issue; siemens determined that maintenance was regularly performed on the system and that quality controls were within expected ranges on the day of the event.Siemens also determined that the reaction kinetics of the affected measurements were correctly elevated by the system.Siemens concluded that a pre-analytical issue potentially caused the discordant, falsely elevated pt inr results.The reagent and system are performing according to specifications.No further evaluation of these devices is required.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) international normalized ratio (inr) result was obtained on a patient sample on a sysmex cs-2100i system, using the thromborel s reagent.The sample was repeated using the same system and reagent, in extended time, resulting lower.The repeat result was reported to the physician(s) and the patient was advised to stop taking warfarin medication.On the next day, the patient was re-drawn and the new sample was run on an alternate system, resulting lower.The initial sample was also repeated on the initial system using the same reagent lot, resulting lower than the initial result.The 2nd repeat result and the redrawn sample result were reported, as the correct results, to the physician(s).There are no known reports of adverse health consequences due to the discordant, falsely elevated pt inr 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: 7878280
• Report Number: 9610806-2018-00093
• Device Sequence Number: 2049512
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: 00842768011337
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/14/2018

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: 04/20/2019
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 562818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1