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	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc)."result doubtful" flags had been obtained on quality controls (qc) run on the affected bcs xp system.A siemens customer service engineer (cse) was dispatched to the customer site.The cse serviced the instrument and found micro bubbles in the sample fluid line.The cse replaced the sample diluter valve and adjusted the reagent and sample syringes.Qc recovered in range after the service intervention.Due to the large difference in results obtained for the affected patient sample, a sample related issue cannot be ruled out.Sample handling issues such as incomplete centrifugation or a sample mix up cannot be ruled as possible causes of the event.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
A discordant, falsely low activated partial thromboplastin time (aptt) result was obtained on a patient sample on a bcs xp system (serial number: (b)(4)) using actin fsl reagent.The discordant result was reported to the physician(s).The sample was repeated for aptt on an alternate bcs xp system (serial number: (b)(4)), recovering higher.This higher result was reported, as the correct result, to the physician(s).The sample was then repeated on bcs xp system (serial number: (b)(4)), also recovering higher.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low activated partial thromboplastin time (aptt) result.

• 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: 12421211
• Report Number: 9610806-2021-00061
• Device Sequence Number: 4648946
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/03/2021

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: 08/11/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR