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

Model Number	DADE INNOVIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that a discordant, falsely low prothrombin time (pt) result and a discordant, falsely low pt international normalized ratio (inr) result were obtained using dade innovin reagent on a sysmex ca-1500 system.Quality controls were within acceptable ranges the day of the event.The customer reported that a sample issue potentially contributed to the discordant, falsely low pt/inr results.Siemens contacted the customer multiple times to gather further information regarding sample handling; however, the customer has not yet responded.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely low prothrombin time (pt) result and a discordant, falsely low pt international normalized ratio (inr) result were obtained using dade innovin reagent on a sysmex ca-1500 system.The discordant results were reported to the physician(s).The same sample was repeated for pt and inr thrice under sample id (b)(6) using the same instrument and the same reagent, resulting higher.The first 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 falsely low pt/inr results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00037 on 19-mar-2019.Additional information (26-mar-2019): siemens further investigated the issue and determined that the issue was sample related.However, the specific cause of the discordant, falsely low prothrombin time (pt) and international normalized ratio (inr) results could not be determined.Inadequate mixing, centrifugation, sample tube type, or mishandling of the sample or reagent could all have been contributing factors to the discordant results.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-35041, ; GM
• MDR Report Key: 8432741
• Report Number: 9610806-2019-00037
• Device Sequence Number: 11017792
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 10/26/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549722A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1