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

Model Number BCS XP SYSTEM

Device Problem Low Test Results (2458)

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

Event Date 11/17/2020

Event Type  malfunction  

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 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
• 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 ; 9145242740
• MDR Report Key: 10993925
• MDR Text Key: 225140809
• Report Number: 9610806-2020-00062
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• 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: 11/17/2020
• Initial Date FDA Received: 12/11/2020
• 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
• Patient Age: 40 YR