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	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that 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 ca-620 system using dade innovin reagent.Quality controls (qc) recovered within range at the time of the event, and only results from one patient sample were reported to be discordant.The customer declined to provide further information, so siemens could not evaluate the cause of the discordant pt and inr results on this one patient sample.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 ca-620 system using dade innovin reagent.The discordant results were reported to the physician(s) and were questioned by the physician(s).A second sample from the same patient was then run for pt and inr, resulting lower.These results were reported, as the correct results, to the physician(s).The following day, the original patient sample was rerun for pt and inr, also resulting lower and confirming the results from the second draw from the previous day.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time and prothrombin time 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: 8941470
• Report Number: 9610806-2019-00070
• Device Sequence Number: 11393152
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: 00630414023472
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 08/28/2019

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: 549732D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1