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	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.No other patient samples were affected.Sample specific issues cannot be ruled out as a potential cause of the event.The reagent used to obtain the von willebrand factor antigen results is a non-siemens reagent and running this reagent on the bcs xp system is a user defined method (udm) that has not been validated by siemens.Siemens is investigating the issue.
Event or Problem Description
Two discordant, falsely low von willebrand factor activity (vwf ac) results and two discordant, falsely low von willebrand factor antigen (vwf ag) results were obtained on a patient sample on a bcs xp system.The vwf ac results were obtained with bc von-willebrand reagent (lot 557480).The vwf ag results were obtained with a non-siemens reagent.The discordant results were reported to the physician(s).Later the same day, the sample was repeated twice more for vwf ac and twice more for vwf ag.The repeat results recovered higher than the initial low results.The sample was also run for factor viii on the same day.The factor viii results recovered in the normal range and were not considered discordant.The following day, the sample was repeated twice more for vwf ac and twice more for vwf ag on an alternate bcs xp system.The repeat results recovered higher and matched the repeat results from the previous day.A corrected report was issued, but it is unknown which results were included in the corrected report.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low von willebrand factor activity and von willebrand factor antigen results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00041 on 22-apr-2021.Additional information (28-apr-2021): the customer received the affected sample as a frozen aliquot from a different lab, and they are not able to confirm any information from the other lab regarding transport, tube type, centrifuge information or if the sample was double-spun.Siemens confirmed that the customer was using correct reagent handling.Controls being in range, no mechanical errors, acceptable precision and no other samples showing problems indicates that the instrument and reagents were performing acceptably.Inadequate mixing, centrifugation or other mishandling of the sample cannot be ruled out as contributing factors to the discordant results.The issue is sample specific and was limited to one patient sample.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• 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: 11711199
• Report Number: 9610806-2021-00041
• Device Sequence Number: 3550310
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• 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): 05/21/2021

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
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1