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	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that four discordant, falsely elevated prothrombin time (pt) results, four discordant, falsely elevated prothrombin time international normalized ratio (inr) results, and two discordant, falsely low prothrombin time percent (pt%) results were obtained on a patient sample on a sysmex cs-5100 system using dade innovin reagent.The customer provided siemens with the system reaction kinetics.All reaction kinetics were correctly evaluated by the system software.Quality controls recovered within range at the time of the event.The cause of the discordant results is unknown, other than that it was single event based on the specific sample.A possible cause is sample contamination with heparin.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Four discordant, falsely elevated prothrombin time (pt) results, four discordant, falsely elevated prothrombin time international normalized ratio (inr) results, and two discordant, falsely low prothrombin time percent (pt%) results were obtained on a patient sample on a sysmex cs-5100 system using dade innovin reagent.After obtaining these discordant results, the same sample was repeated for pt, inr, and pt% on the same system with thromborel s reagent.The pt and inr resulted lower and the pt% resulted higher.A new sample from the same patient was run twice for pt, inr, and pt% on an alternate sysmex cs-5100 system using dade innovin reagent.The pt and inr resulted lower than the results previously obtained using dade innovin reagent and the pt% resulted higher than the results previously obtained using dade innovin reagent.The sample was then repeated again for pt, inr, and pt% on the same alternate sysmex cs-5100 using thromborel s reagent.The pt and inr resulted lower than the results previously obtained using dade innovin reagent and the pt% resulted higher than the results previously obtained using dade innovin reagent.The last inr result obtained with dade innovin reagent was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) results, the discordant, falsely elevated prothrombin time international normalized ratio (inr) results, or the discordant, falsely low prothrombin time percent (pt%) 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: 9309883
• Report Number: 9610806-2019-00085
• Device Sequence Number: 2036355
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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: 07/19/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR