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

Model Number	DADE INNOVIN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that discordant prothrombin time (pt) in seconds and corresponding pt international normalized ratio results were obtained on a patient sample on a sysmex ca-1500 system using dade innovin reagent.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse: verified sample probe integrity; adjusted the sample probe to be more precisely aligned to the center of the tubes; checked all probe tubings for damage, leaks, kinks or other defects and found none; performed alignments of sample and reagent probes; verified mixer operation; performed system decontamination, and verified pt precision.The cse followed up the next day and the customer reported the system remained fully operational.Siemens further investigated the issue and determined that the issue was resolved with routine service tasks performed by the cse.Siemens determined that pre-analytical factors or sample specific issues potentially contributed to the discordant pt results.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) result in seconds with a corresponding, falsely elevated prothrombin time international normalized ratio (inr) result were obtained using dade innovin reagent on a sysmex ca-1500 system.The discordant, falsely elevated pt result with the corresponding inr result were not reported to the physician(s).The sample was repeated for pt using the same reagent lot on another sysmex ca-1500 system, resulting lower.The repeat pt result in seconds result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated pt/inr 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-35041, ; GM
• MDR Report Key: 8452551
• Report Number: 9610806-2019-00039
• Device Sequence Number: 18892307
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/26/2019

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: 11/30/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1