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	07/15/2019
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 and two discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on one patient sample on a sysmex cs-5100 instrument serial number: (b)(4) using thromborel s reagent (lot number: 565656).Siemens reviewed the submitted data files.All reaction kinetics were evaluated correctly by the system software.The reason for the difference between the initial and the reflex results is that the cs-5100 system takes two aliquots.In the case of a pre analytical issue caused by not mixing the patient sample properly, variable results may be obtained.Therefore, a preanalytical issue could have caused the discordant results.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) result and two discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on one patient sample on a sysmex cs-5100 instrument serial number: (b)(4) using thromborel s reagent (lot number: 565656).The discordant results were not reported to the physician(s).The same sample was repeated twice for pt and twice for inr, once on an alternate sysmex cs-5100 instrument serial number: (b)(4) and once on the same sysmex cs-5100 instrument serial number: (b)(4).The repeat 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 discordant, falsely elevated prothrombin time and prothrombin time international normalized ratio 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: 8875650
• Report Number: 9610806-2019-00063
• Device Sequence Number: 2742697
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: 00842768011337
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/08/2019

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: 02/11/2021
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 565656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1