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	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer site to determine the cause of the discordant, falsely elevated prothrombin time (pt) results on the sysmex ca-660 system and found no issues.Siemens cse performed a 10 replicate precision study with normal patient samples on the pt and activated partial thromboplastin time (aptt) assay and the precision study recovered within specifications and with good reproducibility.The cse determined that the quality controls recovered within expected ranges and with good reproducibility.Siemens field service engineer (fse) replaced a probe on the system a day before the event ((b)(6) 2017) and the customer indicated that there were neither systemic error flags nor error flags on the affected patient results.A sample specific issue potentially contributed to the discordant results but the cause of the event is unknown.The system and reagent are performing according to specifications.No further evaluation of this system or reagent is required.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) result and a discordant, falsely elevated pt international normalized ratio (inr) result were obtained on a patient sample on the sysmex ca-660 system.The discordant results were reported to the physician, who questioned the results.The patient was sent to the emergency room (er), where the patient's blood was redrawn and run on the same system, resulting lower.The repeated results were provided to the physician.The original sample was also rerun on the same system, resulting lower than the initial results.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated 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: 7040639
• Report Number: 9610806-2017-00132
• Device Sequence Number: 1358423
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 06/19/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 539388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR