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	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and siemens investigated the sysmex cs-2100i system back up files.Siemens determined that the reaction kinetics was correctly evaluated by the system and that quality controls were within expected ranges at the time of the event.Siemens observed that maintenance was performed regularly and did not identify any system issue.The cause of the discordant, falsely elevated prothrombin time (pt) and pt international normalized ratio results was potentially due to pre-analytical issues.The system and reagent are performing according to specifications.No further evaluation of these devices is required.
Event or Problem Description
Non-numerical prothrombin time (pt) and pt international normalized ratio (inr) results, flagged with "no coagulation", were obtained on a patient sample on a sysmex cs-2100i system with the thromborel s reagent.The sample was repeated on the same system, resulting in discordant, falsely elevated pt and pt inr results.The discordant pt inr result was auto-validated and reported to the physician(s), who questioned the result.The sample was re-centrifuged and repeated on the same system, resulting lower.The patient's blood was also redrawn and run on the same system, resulting lower.The pt inr result, obtained on the redrawn sample, was reported 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: 7771855
• Report Number: 9610806-2018-00080
• Device Sequence Number: 1012228
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2018

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: 06/01/2019
• Device Model Number: THROMBOREL S
• Device Catalogue Number: 10446445
• Device Lot Number: 562828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR