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	09/25/2019
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, a discordant, falsely elevated prothrombin time international normalized ratio (inr) result, and a discordant, falsely low prothrombin time percent (pt%) result were obtained on a patient sample on a sysmex cs-5100 system using dade innovin reagent.The backup files from the sysmex cs-5100 system were sent to siemens for further evaluation.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) result, a discordant, falsely elevated prothrombin time international normalized ratio (inr) result, and a discordant, falsely low prothrombin time percent (pt%) result were obtained on a patient sample on a sysmex cs-5100 system using dade innovin reagent.The same sample was then repeated for pt, inr, and pt% on the same system with dade innovin reagent.The pt and inr resulted lower and the pt% resulted higher.Using thromborel s reagent, the same sample was tested for pt, inr, and pt% on the same system.The pt and inr resulted lower and the pt% resulted higher.The same sample was then repeated for pt, inr, and pt% on an alternate sysmex cs-5100 system using dade innovin reagent.The pt and inr resulted lower and the pt% resulted higher than the initial discordant results.Using thromborel s reagent, the same sample was then repeated for pt, inr, and pt% on the same alternate system.The pt and inr resulted lower and the pt% resulted higher.The following day, a new sample from the same patient was tested for pt, inr and pt% using dade innovin reagent on the same two sysmex cs-5100 systems that were used the previous day.The pt and inr resulted lower than the results obtained using dade innovin reagent the previous day and the pt% resulted higher than the results obtained using dade innovin reagent the previous day.The last inr result obtained with dade innovin reagent 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 (pt) result, the discordant, falsely elevated prothrombin time international normalized ratio (inr) result, or the discordant, falsely low prothrombin time percent (pt%) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00078 on 25-oct-2019.Additional information (28-oct-2019): siemens further investigated the issue.Based on the analysis of the provided kinetics from the sysmex cs-5100 systems, no system or software issue could be identified.Quality controls (qc) recovered within range at the time of the event.All reaction kinetics were correctly evaluated by the system software.The cause of the discordant results obtained with dade innovin and thromborel s reagents is unknown.The issue is most likely caused by sample peculiarities such as preanalytical factors that have a higher impact on the results obtained with dade innovin reagent compared to thromborel s reagent when using the first sample draw in comparison to the later one.The reagent is performing according to specifications.No further evaluation of this device is required.

• 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: 9239823
• Report Number: 9610806-2019-00078
• Device Sequence Number: 1935626
• 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,Followup
• Report Date (Section B): 11/26/2019

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: 07/19/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR