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	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) technical support technician (tst) analyzed data provided by the customer to determine the cause of the discordant, falsely elevated prothrombin time (pt) results on the sysmex ca-1500 system and found no issues.The tst advised the customer to perform a precision study with 10 replicates.The customer obtained errors when they set replicates to 10 and the customer did not want to troubleshoot this issue.Instead, they ran the precision study with 6 replicates and it recovered within expected ranges.The customer refused having service dispatched on site and indicated that no other patient results were impacted.The cause of the discordant results is unknown but is potentially due to sample specific issues.The system and reagent are performing according to specifications.No further evaluation of this system is required.
Event or Problem Description
Discordant, falsely elevated prothrombin time (pt) results were obtained on two patient samples on the sysmex ca-1500 system.The customer reported a discordant, falsely elevated pt result on one patient sample (sid patient 1) to the physician, who questioned the result.Based on the discordant result, the patient was sent to the emergency room and the patient blood was redrawn and tested for pt, resulting in the normal range.The initial patient sample was also rerun on the same system, resulting lower.A corrected report was provided to the physician.The customer did not report any discordant results on the second patient sample (sid (b)(6)) and reran the patient sample twice on the same system, resulting lower than the initial results.The same patient sample was also rerun on an alternate sysmex ca-1500 system, resulting lower.A repeated result was reported to the physician as it matched the patient's clinical history.The customer indicated that the samples were neither hemolyzed, lipemic, icteric nor clotted and that the samples were appropriately filled for both patients.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated 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: 6937213
• Report Number: 9610806-2017-00112
• Device Sequence Number: 483000
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/10/2017

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: 08/10/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 539393
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1