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

Model Number BCS XP SYSTEM

Device Problem High Test Results (2457)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

A discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a bcs xp system.The discordant results were reported to the physician(s).A new sample was drawn from the patient and run for pt and inr, recovering lower.The lower results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant pt and inr results.

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse was unable to duplicate the issue and the customer has not observed this issue since it was first reported.The customer believes the issue was caused due to a bad sample draw.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2022-00046 on 26-aug-2022.Additional information (31-aug-2022): siemens investigation determined that the prothrombin time (pt) measurement curves were evaluated correctly by the bcs xp software.The provided error log file review does not show errors related to the dade innovin reagent, and there were no instrument errors at the time of the event.The siemens customer service engineer (cse) was unable to duplicate the issue and the system is operational.The issue was isolated to the original blood sample collection results and was resolved with a new blood recollection.The customer confirmed that the patient sample was a bad draw.The cause of the event was a pre-analytical issue.The system is performing according to specifications.No further evaluation of this device is required.

• 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: 15302546
• MDR Text Key: 303555008
• Report Number: 9610806-2022-00046
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

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
• 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
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/19/2022
• 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
• Patient Sequence Number: 1