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

Model Number BCS XP SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center and reported that on (b)(6) 2018, a siemens customer service engineer (cse) moved the barbicide and rinse water bottles, used for the bcs xp system, further away from the system.The customer reported that multiple discordant, falsely elevated pt inr results were obtained on the system due to the new location of these bottles.Prior to this event, a cse was dispatched to the customer's site due to an overflowing barbicide issue on the system; siemens determined that the customer performed proper reconstitution of barbicide.The cse checked the tubing from and to the bottles and verified that they were properly connected.The cse also emptied the barbicide tubing and performed multiple liquid dispense corrections, including washing the probes, filling syringes, and determined that no fluids came back into the tube.The customer monitored the barbicide container for three weeks and determined that there was no recurrence of the issue.On 25-apr-2018, a cse was dispatched to the customer's site to determine the cause of the discordant, falsely elevated pt inr results and found no issue.After the cse's visit, the customer moved the barbicide and water bottles to their original locations and reported that no further discordant results or quality control issues were observed.The cause of the discordant, falsely elevated pt inr results is unknown.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely elevated prothrombin time (pt) international normalized ratio (inr) results were obtained on multiple patient samples on the bcs xp system, using the dade innovin reagent.The discordant results were reported to the physician(s), who questioned the results.Due to the discordant pt inr results, the administration of warfarin medication for patients of sample ids (sids) ci, dp, and ev was delayed, the patient of sid pf was treated with a lower dosage of warfarin medication, and the patient of sid jp was unnecessary administered vitamin k.The same samples were rerun on the same system, resulting lower.The repeat results were reported, as the correct results, to the physician(s).The customer reported that twenty additional patients were rerun on (b)(6) 2018, but did not provide the data for these patients.There are no known reports of adverse health consequences due to the discordant, falsely elevated pt inr results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2018-00049 on 25-may-2018.Additional information (05-june-2018): siemens further investigated the issue and determined that the customer's allegation that the relocation of the barbicide bottles potentially contributed to the discordant, falsely elevated prothrombin time (pt) international normalized ratio (inr) results due to dilution is not supported because of the fluidic design of the bcs xp system.Siemens determined that the movement of the external bottles to a different position potentially led to the removal of the intake and waste nozzles and incorrect placement of intake nozzle for system liquids, such as water and barbicide, and waste nozzle potentially contributed to the discordant, falsely elevated pt inr results.There is a potential that the waste nozzle was inserted in the disinfectant bottle, which may have led to the increase in liquid volume as the system was running.It is also possible the water intake nozzle was placed in the waste container.If the system waste was used as "rinse water", it could lead to low concentrations of barbicide contamination, contributing to the discordant, falsely elevated coagulation results.Siemens customer service engineer was unable to duplicate the issue.

• Brand Name: BCS XP SYSTEM
• Type of Device: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7545435
• MDR Text Key: 109752760
• Report Number: 9610806-2018-00049
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1