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

Model Number BN II SYSTEM

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that the bn ii system released incorrect free light chains, type kappa (flc kappa) results to a non-siemens host.Siemens analyzed the submitted data file and system logs file; no similar occurrences have been reported from the customer prior to and post the event.The use of the non-siemens reagent on the bn ii system is not validated by siemens (off-label).Siemens is investigating the issue.

Event Description

A customer reported that incorrect free light chains, type kappa (flc kappa) results (with technical flags) were released by the bn ii system for two patient samples to a non-siemens host.The results were obtained using a non-siemens reagent on the bn ii system.The results were not released to the physician(s).Both samples were rerun with multiple higher dilutions on the same instrument and higher results were obtained on the samples.The results obtained using the 1:2000 dilution 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 incorrect results released by the bn ii system.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00046 on 02-may-2019.Additional information (10-may-2019): siemens headquarters support center (hsc) reviewed the data provided and determined there was no indication of a system nor reagent malfunction.All results mentioned in the initial mdr and recorded in the communication protocol match up perfectly with the lab journal print-out forwarded by the customer.There is no evidence of any malfunction or wrong assignment of sample identification numbers (ids) and measured values as initially assumed.An issue with the sample preparation or the test definition which was entered for the binding site free light chain assay could potentially have been the cause.Siemens recommended checking these two parameters to possibly improve the sample processing of this method that is not validated by siemens.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: 8575434
• MDR Text Key: 143989082
• Report Number: 9610806-2019-00046
• Device Sequence Number: 0
• Product Code: DFH
• Combination Product (y/n): N
• PMA/PMN Number: K943997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BN II SYSTEM
• Device Catalogue Number: 10462274
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1