MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BERICHROM ANTITHROMBIN III

Catalog Number	10446672
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, low atiii patient sample result on the atellica coagulation 360 system.No product non-conformance could be identified and a possible cause of the event may be related to sample handling.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, low berichrom antithrombin iii (atiii) patient sample result of <15% was generated on the atellica coag 360 system and was not reported to the physician.The same sample was tested again on the same system and an atiii result of 95.2% was generated.The same patient sample was repeated on a bcs xp system and an atiii result (not provided by customer) was generated that was consistent with the 95.2% result on the atellica coag 360 system.All quality control results were within range.There are no reports of patient intervention or adverse health consequence due to the discordant, low atiii result.

• Brand Name: BERICHROM ANTITHROMBIN III
• Common Device Name: BERICHROM ANTITHROMBIN III
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 6986810
• Report Number: 9610806-2017-00119
• Device Sequence Number: 649015
• Product Code: JPE
• UDI-Device Identifier: 00842768013461
• UDI-Public: 00842768013461
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K933125
• 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): 10/30/2017

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: 11/10/2018
• Device Catalogue Number: 10446672
• Device Lot Number: 46999
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/30/2017
• 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