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	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that the reagent volume was low during the initial and repeat analyses of the affected sample.The customer is currently holding elevated pt inr results for validation in their middleware; when they obtain a doubtful result, the customer repeats the sample prior to reporting the result.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 and 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) and a discordant, falsely elevated pt international normalized ratio (inr) result were 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 customer repeated the sample after replacing the low volume reagent vial with a new thromborel s reagent vial from the same lot.The 2nd repeat results recovered lower and 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 pt and 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: 7878258
• Report Number: 9610806-2018-00092
• Device Sequence Number: 2218161
• 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