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

Model Number	BCS XP SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls failed, after which the customer noticed they did not remove the rinse float from the barbicide container after performing tube disinfection on their bcs xp system.The customer set the rinse float back in the rinse bottle, replaced the reagents, and performed rinses.Quality controls were then rerun and recovered within acceptable ranges.The instrument is now fully operational.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low d-dimer result was obtained on a bcs xp system using innovance d-dimer reagent.The discordant result was reported to the physician(s).The same sample was repeated for d-dimer two times on an alternate bcs xp system, once using the d-dimer low application and once using the d-dimer high application.Both results recovered higher than the initial discordant result.The patient was redrawn and the redrawn sample was run for d-dimer on the same alternate bcs xp system, once using the d-dimer low application and once using the d-dimer high application.Both results recovered higher than the initial discordant result.The higher repeat results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low d-dimer result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2020-00049 on 06-oct-2020.Additional information (06-oct-2020): section d8 of the mdr was changed from "unknown" to "no".

• Brand Name: BCS XP SYSTEM
• Common Device Name: 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: 10635771
• Report Number: 9610806-2020-00049
• Device Sequence Number: 19622766
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K970431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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 Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1