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

Model Number	BN PROSPEC SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the patient was monitored for kappa and lambda for some time using electrophoresis and the alternate non-siemens method.The customer recently started using siemens n latex flc lambda and n latex flc kappa reagents for determination of flc lambda and flc kappa.A siemens headquarters support center (hsc) specialist reviewed the data files on the bn prospec system to determine the cause of the event and found no issue.The hsc specialist determined that the save data files contained two quality control (qc) measurements and these results were within expected ranges.The hsc specialist also reviewed the qc kinetics and did not identify any issue.The hsc specialist concluded that there was no indication of a reagent or system malfunction.The cause of the event is unknown.The system and reagents are performing according to specifications.No further evaluation of these devices is required.Mdr 9610806-2018-00035, mdr 9610806-2018-00036, and mdr 9610806-2018-00038 were filed for the same event.
Event or Problem Description
A discordant, falsely low free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on the bn prospec system using the n latex flc lambda reagent.The result did not match the patient's clinical history and it is unknown whether this result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc lambda result.
Additional Manufacturer Narrative
Additional information (05-apr-2018): the customer reported that the sample initially ran on (b)(6) 2018 was rerun using an alternate non-siemens' reagent on (b)(6) 2018, resulting higher.Mdr 9610806-2018-00035_s1, mdr 9610806-2018-00036_s1, and mdr 9610806-2018-00038_s1 were filed for the same event.
Event or Problem Description
The sample was rerun using a non-siemens' reagent, on the same system, resulting higher.

• Brand Name: BN PROSPEC SYSTEM
• Common Device Name: BN PROSPEC SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7397585
• Report Number: 9610806-2018-00037
• Device Sequence Number: 10901435
• Product Code: JZW
• UDI-Device Identifier: 00630414002736
• UDI-Public: 00630414002736
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K001647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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: BN PROSPEC SYSTEM
• Device Catalogue Number: 10465217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1