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

Model Number	DADE INNOVIN
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that two discordant, falsely elevated prothrombin time (pt) results, two discordant, falsely low prothrombin time percent (pt%) results, and two discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on two samples from the same patient on a sysmex cs-5100 system using dade innovin reagent.As stated in the interfering substances section of the instructions for use for dade innovin reagent, "inhibitors such as lupus anticoagulant may interfere with the prothrombin time and result for example in inrs that do not reflect the exact degree of anticoagulation." this could have contributed to the discordant results.Report source indicates that the instrument manufacturer, sysmex europe (b)(4), reported this incident to siemens.They provided the complaint from one of their customers.Siemens is investigating the issue.Mdrs 9610806-2019-00053, 9610806-2019-00054, and 9610806-2019-00055 were filed for additional results for samples from the same patient.
Event or Problem Description
Two discordant, falsely elevated prothrombin time (pt) results, two discordant, falsely low prothrombin time percent (pt%) results, and two discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on two samples from the same patient on a sysmex cs-5100 system using dade innovin reagent (lot#: 549716).The discordant results were reported to the physician(s), and the results were questioned by the physician(s).The following day, a different sample from the same patient was run for pt% and inr on a non-siemens instrument with unknown reagent, resulting in higher pt% and lower inr results.The repeat results were reported, as the correct results, to the physician(s).Due to the discordant falsely elevated pt and pt inr results and the discordant falsely low pt% results, vitamin k reversal therapy was started on the patient; however, there were no adverse health consequences to the patient as a result of the vitamin k reversal therapy.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00052 on 13-jun-2019.Additional information (19-jun-2019): siemens further investigated the issue.According to the information provided, lupus anticoagulant (la) is present in the patient sample.La is known to interfere with the dade innovin reagent which is described in the dade innovin instruction for use (ifu): "inhibitors such as lupus anticoagulant may interfere with the prothrombin time and result for example in inrs that do not reflect the exact degree of anticoagulation".The discrepant results are due to the la interferences as described in the dade innovin ifu.Result code and conclusion code in section h6 were updated based on the additional information.Supplemental mdrs 9610806-2019-00053_s1, 9610806-2019-00054_s1, and 9610806-2019-00055_s1 were filed for additional results for samples from the same patient.The reagent is performing according to specifications.No further evaluation of this device is required.

• 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: 8696693
• Report Number: 9610806-2019-00052
• Device Sequence Number: 2663326
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: Other
• Device Expiration Date: 08/29/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1