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 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has determined that the cause of the discordant patient results on four separate patient samples observed on the bcs xp system (serial number (b)(4)) between the three (3) prothrombin time (pt) assays (pt, ptx (extended clot time), pt570) was due to a loose sample syringe plunger connector.The siemens field service engineer replaced the sample probe and sample tubing.Validation and quality control were run with acceptable recovery.The system was operational upon departure.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant patient results on four separate patient samples were observed on a bcs xp system (serial number (b)(4)) between the three (3) prothrombin time (pt) assays (pt, ptx (extended clot time), pt570).None of these results were reported to the physician.Pt quality control recovered within range.The same patient samples were repeated on an alternate bcs xp system (serial number (b)(4)) and generated pt patient results that matched the pt570 patient results generated on the bcs xp (serial number (b)(4)).Pt patient results were reported from the alternate bcs xp system (serial number (b)(4)).No erroneous results were reported.There are no reports of patient intervention or adverse health consequences due to the discordant pt patient results generated on the bcs xp system (serial number (b)(4)).

• 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: 7283424
• MDR Text Key: 100774247
• Report Number: 9610806-2018-00028
• 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: 02/20/2018

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: 01/26/2018
• Initial Date FDA Received: 02/20/2018
• 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