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

Model Number BCS XP SYSTEM

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

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 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.

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
• 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: 10635771
• MDR Text Key: 214805553
• Report Number: 9610806-2020-00049
• 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: 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
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1