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	01/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that discordant, falsely high pt and inr results were obtained on a sysmex ca-1500 system using the dade innovin reagent.Siemens is investigating the issue.
Event or Problem Description
Discordant, falsely high pt (prothrombin time) and inr (international normalized ratio) sample results were obtained on one patient using a sysmex ca-1500 system and the dade innovin reagent.The results were auto repeated and those results were reported to the physician(s), who questioned the results.A new sample was drawn from the patient and yielded lower results.These results were reported to the physician(s) as correct.The original sample was checked for clots, centrifuged again and retested resulting lower.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely high pt and inr results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2020-00006 on 13-feb-2020.Additional information (17-feb-2020): quality controls (qc) recovered in range at the time of the event.There were no instrument flags associated with the affected patient results, and no other patient samples were impacted.Pre-analytical variables (such as a delay in mixing the samples after collection or insufficient mixing) or patient specific issues (such as effects of medications and other interferences listed in the reagent instructions for use (ifu)) could not be excluded.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-350 41; GM D-35041
• MDR Report Key: 9707661
• Report Number: 9610806-2020-00006
• Device Sequence Number: 11608422
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 02/01/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549729A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR