MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN II SYSTEM

Model Number BN II SYSTEM

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that discordant, falsely elevated albumin results were intermittently obtained on patient samples on a bn ii system for a couple of weeks.However, the customer did not provide the data for the other patients impacted prior to (b)(6) 2018.The customer indicated that albumin was the only assay impacted by this issue and that re-calibrating the assay did not resolve the issue.A siemens customer service engineer was dispatched to the customer's site multiple times.During these visits, the cse: inspected the system performance during a precision run; adjusted the sample wash level; tightened the loose connections on brass valve 1; verified that wash was sufficiently delivered to cuvettes; replaced and aligned the sample probe; replaced dilutor valves, 2500 ul leaky syringe valve, 2/3 way solenoid valve, vacuum pump and two syringes; ran quality controls (qcs), precision tests and calibrations, which recovered acceptably.Siemens further analyzed the instrument files and did not find any issue with the calibration or qc data.The cause of the discordant, falsely elevated albumin results is unknown.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely elevated albumin results were obtained on two patient samples on a bn ii system.The discordant results were not reported to the physician(s).The samples were repeated on the same system twice, resulting lower.The 2nd repeat 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, falsely elevated albumin results.

Manufacturer Narrative

Siemens filed the initial mdr on 15-oct-2018.Additional information (22-oct-2018): a siemens customer service engineer (cse) returned to the customer's site.During this visit, the cse replaced and aligned the reagent probe, adjusted the mixer and temperature on the system, and ran quality controls (qcs) and a precision test, which recovered within expected ranges.The customer provided additional system files and upon further investigation, siemens determined that there were no issues with the calibration curves.The cause of the discordant, falsely elevated albumin results is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: BN II SYSTEM
• Type of Device: BN II SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7966906
• MDR Text Key: 123822307
• Report Number: 9610806-2018-00106
• Device Sequence Number: 0
• Product Code: CIX
• Combination Product (y/n): N
• PMA/PMN Number: K943997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/20/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BN II SYSTEM
• Device Catalogue Number: 10459300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1