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	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics (siemens) headquarters support center (hsc) specialist analyzed the calibration data and the patient results to determine the cause of the discordant, falsely low results on multiple assays on the bn prospec system.The hsc specialist determined that all assays were calibrated and the calibration curves recovered as expected.Since the affected bn prospec system save data files were not provided for further evaluation, the cause of the event is unknown.The repeat results were obtained using the same reagent lots and system as the initial results.Due to this, the hsc specialist determined that the system and reagents are performing according to specifications.No further evaluation of this system is required.
Event or Problem Description
Discordant, falsely low immunoglobulin g (igg), immunoglobulin a (iga), immunoglobulin m (igm), and bound and free lambda type of human immunoglobulin light chains (ig/l chain, type lambda) results were obtained on a patient serum sample on the bn prospec system.The sample was also tested for bound and free kappa type of human immunoglobulin light chains (ig/l chain, type kappa), resulting within expected ranges.All these results were reported to the physician, who questioned the discordant, falsely low results.The same sample was rerun for igg, ig/l chain, type lambda, and ig/l chain, type kappa on the same system.Other low discordant results were obtained for igg and ig/l chain, type lambda.Upon repeat, discordant, falsely low ig/l chain, type kappa results were obtained at 1:20 dilution on the patient sample.On (b)(6) 2018, the same patient sample was retested for all parameters, except ig/l chain, type kappa, on the same system, resulting higher than the initial results.These results were more plausible for this patient and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low results obtained on the patient sample.

• 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: 7275386
• Report Number: 9610806-2018-00026
• Device Sequence Number: 19126988
• Product Code: JZW
• UDI-Device Identifier: 00630414002736
• UDI-Public: 00630414002736
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 02/15/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR