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	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.Sample collection and handling issues cannot be excluded.It is unknown if the tube was sufficiently gently mixed 3-6 times immediately after blood collection or if the centrifuge time and speed was appropriate.It is also unknown if the patient received blood plasma substitutes that contain hydroxyethyl starch that may interfere with the analysis per the dade innovin instructions for use (ifu).There were no instrument errors and no other patient results were affected, indicating that the issue is sample specific.The cause of the discordant, falsely elevated prothrombin time (pt) results and prothrombin time international normalized ratio (inr) results obtained on a patient sample on a sysmex ca-620 system using dade innovin reagent is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Three discordant, falsely elevated prothrombin time (pt) results and three discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on a patient sample on a sysmex ca-620 system using dade innovin reagent.The discordant results were not reported to the physician(s).The sample was sent to another hospital to be rerun for pt and inr.The pt and inr both resulted lower.These results were reported, as the correct results, to the physician(s).The sample was then sent back to the customer's lab to be rerun again for pt and inr.The pt and inr resulted lower and matched the results from the other hospital.There are no reports of patient intervention or adverse health consequences due to the three discordant, falsely elevated prothrombin time (pt) results and three discordant, falsely elevated 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: 9904389
• Report Number: 9610806-2020-00010
• Device Sequence Number: 19008059
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• 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): 03/31/2020

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: 07/18/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1