MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

Catalog Number 10459330

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has determined that the cause of the incorrectly entered international sensitivity index (isi) value (1.03 instead of 0.89) in the software settings of the bcs xp system was due to an operator error.The customer corrected the isi value in the software settings of the bsc xp system to 0.89 and the instrument is now calculating the correct international normalized ratio (inr) results.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2018-00006 was filed for the same event.

Event Description

An incorrect international sensitivity index (isi) value (1.03 instead of 0.89) was entered into the software settings of the bcs xp system for innovin lot 549708, which was in use by the customer for the past several months.Use of an incorrect isi value may cause an inr patient result to be falsely high.Patient samples were run during this time and international normalized ratio (inr) results were reported to physicians.The issue was detected by a (b)(6) survey report with three (3) sample inr results outside of the expected range.No specific patient data was provided by the customer.There are no reports of patient interventions or adverse health consequences due to the incorrect isi value.

• Brand Name: BCS XP SYSTEM
• Type of Device: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• Manufacturer Contact: loriann russo ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242287
• MDR Report Key: 7169645
• MDR Text Key: 97597925
• Report Number: 9610806-2018-00005
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/05/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1