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

Catalog Number	10445706
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.Has investigated the provided information to determine the cause of the discordant low prothrombin time (pt) patient result generated on the sysmex ca-560 analyzer.The cause of the event is due to improper mixing and handling of the sample.No product non-conformance nor system issue could be identified.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2018-00029 was filed for the same event.
Event or Problem Description
A discordant, low prothrombin time (pt) patient result of 13.1 seconds was generated on sysmex ca-560 analyzer.The pt result was not reported to the physician.Quality control was within range.The same sample was repeated twice on the same system and pt results of 32.0 seconds and 31.9 seconds were generated.The pt result of 32.0 seconds was reported to the physician.There are no reports of patient intervention or adverse health consequences due to the discordant pt patient result.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 7310455
• Report Number: 9610806-2018-00030
• Device Sequence Number: 1250730
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 03/02/2018

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: 01/21/2019
• Device Catalogue Number: 10445706
• Device Lot Number: 539378
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1