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

Model Number	DADE INNOVIN
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect Or Inadequate Test Results (2456); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The operator replaced the lamp on the sysmex cs-2100i system.Siemens healthcare diagnostics (siemens) is investigating the issue.Mdr 9610806-2017-00154 was filed for the same event.
Event or Problem Description
On (b)(6) 2017, a discordant, falsely elevated prothrombin time (pt) result, a discordant, falsely elevated pt international normalized ratio (inr) result, and a discordant, falsely low pt % result were obtained on a patient sample on the sysmex cs-2100i system.These discordant results were reported to the physician(s), who did not question the results.Due to the discordant results, the patient was administered an additional dosage of vitamin k.The patient's blood was redrawn and run on the same system, resulting in a lower pt result, a lower pt inr result and higher pt% result.On (b)(6) 2017, the initial sample was rerun on the same system, in duplicate, resulting in lower pt results, lower pt inr results and higher pt% results than the initial results.A corrected report was provided to the physician(s), but the results in the corrected report are unknown.There are no known reports of adverse health consequences due to the discordant, falsely elevated pt result, discordant, falsely elevated pt inr result, and discordant, falsely low pt % result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics (siemens) filed the initial mdr 9610806-2017-00153 on 28-dec-2017.Additional information (18-jan-2018): a siemens headquarters support center (hsc) specialist investigated the sysmex cs-2100i system's backup files and determined that the system was functioning according to specifications.The hsc specialist also determined that maintenance was regularly performed on the system, quality controls (qcs) were within expected ranges at the time of the event, and that the system correctly inspected the affected kinetics.A pre-analytical issue potentially contributed to the discordant results.Additional information (23-jan-2018): sysmex is the legal manufacturer of the sysmex cs-2100i system.Since the operator did not provide the malfunctioned lamp for further investigation and the age of the bulb is unknown, sysmex determined that the lifetime of the bulb was potentially exceeded.This potentially contributed to the discordant results.The cause of the event is unknown.The system and reagent are performing according to specifications.No further evaluation of this system or reagent is required.Mdr 9610806-2017-00154_s1 was filed for the same event.

• 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: 7152259
• Report Number: 9610806-2017-00153
• Device Sequence Number: 11056341
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 04/21/2018
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 539352
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1