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	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results were obtained on a patient sample on a sysmex cs-2500 system using dade innovin reagent.Quality controls recovered within range at the time of the event.There were no hardware errors, no bubbles in the sample or reagent, and no other samples were affected.Sample handling issues as well as interferences due to the patient's medications cannot be ruled out.The cause of the discordant, falsely elevated pt and inr results is unknown.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 and a discordant, falsely elevated prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a sysmex cs-2500 system using dade innovin reagent.A second discordant, falsely elevated pt result and a second discordant, falsely elevated inr result were obtained after the same sample was automatically remeasured for pt and inr.The automatically remeasured results were reported to the physician(s) and were questioned by the physician(s).The same sample was repeated again for pt and inr, resulting lower.A new sample from the same patient was then run for pt and inr, also resulting lower.The pt and inr results obtained from the new sample were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (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-350 41; GM D-35041
• MDR Report Key: 9628553
• Report Number: 9610806-2020-00003
• Device Sequence Number: 11491451
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/24/2020

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: 11/16/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1