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

Model Number BCS XP SYSTEM

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) inquiring if there was a potential for carryover of emicizumab on the bcs xp systems.Siemens internal investigations revealed that there was a potential emicizumab carryover on patient samples for the low factor viii clotting applications.An urgent medical device correction (umdc) ph21-003.A.Us ("bcs xp system - potential carryover of emicizumab by patient samples") was sent to us customers and an urgent field safety notice (ufsn) ph21-003.A.Ous ("bcs xp system - potential carryover of emicizumab by patient samples") was sent to outside the us (ous) customers in march 2021.The umdc and ufsn explain that the bcs xp system may be affected by a potential emicizumab carryover on patient samples.Only the low factor viii clotting applications may be affected by this issue.Patient samples with factor viii concentrations above 15% of norm, measured in the normal factor viii clotting applications, are not affected.Siemens determined that an intensive washing after the measurement of an emicizumab patient sample can eliminate the potential carryover.Siemens recommends to measure patient samples with known emicizumab treatment in batch mode, followed by an intensive washing cycle of the sample probe using a washing solution.Additionally, results of hemophilia patients measured with any factor viii low application should be carefully reviewed considering clinical history.To date, there are no allegations of injury due to this behavior.

Event Description

The customer contacted siemens requesting information about the effects of emicizumab carryover on the bcs xp system.The customer did not obtain discordant patient results due to this issue.There are no known reports of patient intervention or adverse health consequences due to this 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
• 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 10591 ; 9144153450
• MDR Report Key: 11531573
• MDR Text Key: 246473957
• Report Number: 9610806-2021-00026
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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: 03/02/2021
• 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
• Removal/Correction Number: 9610806-03/15/2021-001-C
• Patient Sequence Number: 1