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	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely high prothrombin time (pt) and international normalized ratio (inr) results were obtained on a sysmex ca-620 system using the dade innovin reagent.Siemens investigation has determined that the customer did not use the correct tube type for the sample with discordant results.Original sample was tested in a bd 1.8 ml tube which is outside of the sysmex ca-600 system specifications per the operator's manual section for sample preparation.Unable to rule-out issues with sample handling.Controls recovered in range and no report of problems with other samples indicates that reagent and instrument were performing as intended.Customer is operational and there is no indication of a systemic product problem.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely high prothrombin time (pt) and international normalized ratio (inr) results were obtained on a sysmex ca-620 system using the dade innovin reagent.The discordant results were reported to the physician(s).Quality controls had been run prior to processing of patient samples and results were within range according to the table of assigned values (tav).The physician questioned the reported result.A new sample was drawn from the patient and was repeated on the same sysmex ca-620 system resulting lower.This result was considered as correct and a corrected report was submitted to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high prothrombin time and international normalized ratio results.

• 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: 9316010
• Report Number: 9610806-2019-00086
• Device Sequence Number: 11253270
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: 00630414023472
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/13/2019

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: 03/22/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873566
• Device Lot Number: 549732B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1