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 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer's site to determine the cause of the discordant prothrombin time (pt) results.The cse replaced the disinfectant pump unit, interface p board, hc11d in the interface p board, pelt board, and x-y com cable for both arms and cse adjusted the 5v and 24v supply.The cse restored globals and eeprom parameters and cleared errors.The cse performed diagnostic checks with no issues and ran internal quality controls, which recovered within range.The cause of the discordant results is unknown.The system and reagents are performing according to specifications.No further evaluation of this system is required.

Event Description

Discordant, falsely elevated prothrombin time (pt) results were obtained on 9 patient samples on the bcs xp system.These results were reported to the physician(s), who did not question the results.One patient ((b)(4)) was treated with a dose of vitamin k due to the discordant result.The same patient samples were rerun at another facility on an alternate bcs xp system, resulting lower.Corrected reports were provided to the physician(s).A discordant, falsely low pt result was obtained on another patient sample on the same bcs xp system.The result was reported to the physician, who did not question the result.The same patient sample was rerun at the other facility on the other bcs xp system, resulting higher.A corrected report was provided to the physician.There are no known reports adverse health consequences as the customer informed the registered nurse (rn) about the discordant results and advised the rn to not act on the discordant results.The customer indicated that the hospital's internal audit, performed by the quality assurance department, indicated that no adverse patient care or harm occurred.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 6904321
• MDR Text Key: 89501920
• Report Number: 9610806-2017-00106
• 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: 09/29/2017

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
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/29/2017
• 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