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

Model Number	DADE INNOVIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc).The customer indicated the sample was checked for clots, hemolysis, icterus and lipemia and no issues were observed.The customer also indicated that quality controls recovered within expected ranges on the day of the event and that there were no error messages on either sysmex cs-5100 systems.Siemens determined that a pre-analytical issue (specific sample characteristics, blood collection, transportation, sample processing/handling in the laboratory) potentially contributed to the discordant, falsely elevated pt inr results.Siemens was previously dispatched to the customer's site to evaluate and discuss pre-analytical conditions with the customer.The system and reagents are performing according to specifications.No further evaluation of these systems or reagents is required.
Event or Problem Description
Flagged, non-numerical prothrombin time (pt), pt % and pt international normalized ratio (inr) results were obtained on a patient sample, using the dade innovin reagent, on two sysmex cs-5100 systems.The sample was rerun in extended time using the dade innovin reagent three times, resulting in discordant, falsely elevated pt inr results.The same sample was rerun on one of the sysmex cs-5100 systems, using the thromborel s reagent, resulting in a lower pt inr result.None of these results were reported to the physician(s).On the next day, a new sample from the patient was run on one of the sysmex cs-5100 systems, using the dade innovin reagent, and on the other sysmex cs-5100 system, using the thromborel s reagent.Pt inr results lower than the discordant, falsely elevated pt inr results, obtained using the dade innovin reagent, were obtained on the new sample.The final pt inr result of 4.94 inr, obtained using the dade innovin reagent, was reported to the physician(s) as it corresponded to the patient's medical conditions.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated pt 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: 7526944
• Report Number: 9610806-2018-00048
• Device Sequence Number: 19234230
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 04/20/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR