MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number	DADE INNOVIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Siemens determined that pre-analytical issues (specific sample characteristics, blood collection, transportation, and/or sample processing/handling in the laboratory) potentially contributed to the discordant results.Siemens specialists were previously dispatched to the customer's site to evaluate and discuss pre-analytical handling conditions with the customer.The medical device is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated prothrombin time international normalized ratio (inr) (extended) result was obtained on a patient sample on a sysmex cs-5100 system (serial number: (b)(4)) using dade innovin reagent.The sample was also run at same time for prothrombin time (pt), prothrombin time percent (pt%), and inr, but the system did not yield numeric results.The same sample was repeated for pt, pt%, and inr on an alternate sysmex cs-5100 system (serial number: (b)(4)) using thromborel s reagent, resulting lower.The same sample was then repeated twice for pt, pt%, and inr on the first sysmex cs-5100 system (serial number: (b)(4)) with dade innovin reagent, all resulting lower.The second repeat inr result was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time international normalized ratio (inr) result.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 9934906
• Report Number: 9610806-2020-00013
• Device Sequence Number: 16318763
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974343
• 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): 04/07/2020

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: 10/01/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR