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 Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.The affected sample was a frozen sample, and it is unknown how long the sample had been frozen before the initial discordant results were obtained.Sample handling issues cannot be ruled out.If the sample was not correctly thawed and mixed the sample may not have been a homogeneous plasma matrix.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Two discordant, falsely low von willebrand factor activity (vwf ac) results were obtained on a patient sample on a bcs xp system (serial number: (b)(4)) with bc von willebrand reagent (lot 557470).The patient sample was previously frozen prior to the initial discordant results being obtained.The discordant results were reported to the physician(s) and were questioned.The same sample was also run for von willebrand factor antigen (vwf ag) and factor viii on the same day.These results were also reported to the physician(s) and it is unknown if they were considered discordant.The sample was re-frozen and was rerun twice for vwf ac seven days later, recovering higher.These 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 von willebrand factor activity (vwf ac) results.

• 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): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, ny ; 5242740
• MDR Report Key: 10478476
• MDR Text Key: 205485893
• Report Number: 9610806-2020-00044
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• 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