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

Model Number	BCS XP SYSTEM
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: 11531573
• Report Number: 9610806-2021-00026
• Device Sequence Number: 3996879
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 03/19/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9610806-03/15/2021-001-C
• Patient Sequence Number: 1