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

Model Number BN PROSPEC SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics (siemens) analyzed the kinetic curves to determine the cause of the discordant, falsely low results obtained on the patient sample on the bn prospec system and determined that turbidity, not due to the sample reaction, potentially contributed to the discordant results.This was potentially caused by insufficient centrifugation of the sample prior to running the sample.Upon further investigation, siemens determined that a sample specific or pre-analytical issue potentially contributed to the discordant results since discordant results were obtained for multiple assays on the affected sample.Siemens also determined that the operator centrifuged samples at a sufficient time and speed, but recommended that the operator increase their centrifuge time.Siemens provided a table with recommended sample storage time, for each assay, to the operator.On (b)(6) 2018, the operator informed siemens that they increased their centrifuge time and reported that they obtained imprecise a1-antitrypsin and immunoglobulin m (igm) results on riqas proficiency testing samples.The operator indicated that they were running patient samples and quality controls routinely and quality controls were recovering within expected ranges.A siemens headquarters support center (hsc) specialist analyzed the bn prospec system files to determine the cause of the imprecise a1-antitrypsin and igm results obtained on the riqas proficiency testing samples and found no issue.The hsc specialist indicated that the kinetic curves recovered as expected and that the bit values for these assays correlated to the concentration results.There were no errors in the error log files that potentially contributed to the imprecise results.The cause of the event is unknown.The system and reagents are performing according to specifications.No further evaluation of this system is required.The operator reported that two patient samples (sample id (b)(6)) were impacted by this event.Mdr 9610806-2018-00024 was filed for sample id (b)(6) and mdr 9610806-2018-00025 was filed for sample id (b)(6).

Event Description

Discordant, falsely low immunoglobulin g (igg), immunoglobulin a (iga), immunoglobulin m (igm), kappa, lambda, haptoglobin and beta 2- microglobulin results were obtained on a patient sample on the bn prospec system.These results were not reported to the physician(s).The same sample was rerun on the same system, resulting higher than the initial results.The repeat results were the correct results 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 igg, iga, igm, kappa, lambda, haptoglobin and beta 2- microglobulin results.

Manufacturer Narrative

Siemens healthcare diagnostics (siemens) filed the initial mdr 9610806-2018-00025 on 13-feb-2018.Additional information (14-feb-2018): mg/dl is the unit for the following assays: immunoglobulin g (igg), immunoglobulin a (iga), immunoglobulin m (igm), kappa, lambda, and haptoglobin.The unit for the beta-2-microglobulin results is mg/l.Corrected information (14-feb-2018): the initial mdr indicated that it was unknown whether the kappa and lambda results were referring to free light chains or bound and free determinations.Upon further investigation, siemens determined that the kappa and lambda results, in the initial mdr, were determinations of bound and free kappa and lambda types of human immunoglobulin light chains.Mdr 9610806-2018-00024_s1 was filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2018-00025 on 13-feb-2018.Siemens filed the initial supplemental mdr 9610806-2018-00025 _s1 on 09-mar-2018.Additional information (23-feb-2018): a siemens field service engineer (fse) was dispatched to the customer's site; the fse ran precision tests prior to and after replacing the diluter valve and electronic board and installed an uninterruptible power supply (ups) with isolation transformer.The precision tests recovered within expected ranges, which supports that the system is functioning according to specifications.Additional information (13-mar-2018): a siemens headquarters support center (hsc) specialist reviewed the data and determined that the service performed will resolve issues related to the wet system on the bn prospec system.The installation of the ups will minimize interference of electronic noise and/or electrical instability from the main power supply and, therefore, will reduce the probability of sporadic issues.The system is performing according to specifications.No further evaluation of this system is required.Mdr 9610806-2018-00024_s2 was filed for the same event.

• Brand Name: BN PROSPEC SYSTEM
• Type of Device: 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: 7266710
• MDR Text Key: 100265909
• Report Number: 9610806-2018-00025
• Device Sequence Number: 1
• Product Code: JZW
• Combination Product (y/n): N
• PMA/PMN Number: K001647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BN PROSPEC SYSTEM
• Device Catalogue Number: 10461865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1