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	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The bcs xp software appropriately flagged results below the measurement range.Siemens is unable to rule out the effects of pre-analytical variables such as blood sample collection, handling and storage or any patient medication and interferences on the results.Heparin controls in range with both assays, no instrument errors, and no other patients affected indicate that the issue was sample specific.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely low heparin results were obtained on a patient sample on a bcs xp system using a non-siemens assay.The discordant results were reported to the physician(s).After recalibrating the non-siemens assay, the sample was repeated for heparin on the same bcs xp system using the same non-siemens reagent, resulting higher.This result was reported, as the correct result, to the physician(s).The sample was also repeated one more time on the bcs xp using innovance heparin reagent, resulting higher and confirming the higher result obtained with the non-siemens reagent.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin results.

• 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: 10993925
• Report Number: 9610806-2020-00062
• Device Sequence Number: 792297
• 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): 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): 12/11/2020

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
• 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: 11/17/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR