MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

Model Number BCS XP SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that discordant, falsely low fibrinogen results were obtained on two samples from the same patient on a bcs xp system using the fib low 570 assay protocol; additionally, the customer provided the imprecise prothrombin time (pt), pt % and pt international normalized ratio (inr) results obtained on the samples.The customer reported that the issue is observed on two bcs xp systems at the laboratory, but did not provide the data to support their report.The fib570 assay protocol is used as a backup for icteric, hemolyzed or lipemic samples that could not be processed with the fib assay protocol.The fib low assay protocol is used for samples with expected fibrinogen concentration below the normal range that cannot be processed with fib assay protocol.Siemens is investigating the issue.Mdr 9610806-2019-00004 was filed for the discordant result(s) obtained on (b)(6) 2018 for sample id (b)(6) and mdr 9610806-2019-00005 was filed for the discordant result(s) obtained on (b)(6) 2018 for sample id (b)(6) from the same patient.

Event Description

A discordant, falsely low fibrinogen (fib) result was obtained on a patient sample on a bcs xp system, using the fib low570 assay protocol.The discordant result was not reported to the physician(s).The sample was previously tested for fib on the same system using the fib and fib570 assay protocols, and compared to the discordant result, higher results were obtained using the fib and fib570 assay protocols.The result obtained using the fib570 assay protocol was considered to be correct and was reported to the physician(s).Additionally, imprecise prothrombin time (pt), pt %, and pt international normalized ratio (inr) results were obtained on the sample using the dade innovin reagent and same system.The correct pt %, pt and pt inr results for this patient are unknown and it is unknown if any of the pt %, pt and pt inr results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low fibrinogen result and imprecise pt %, pt and pt inr results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00004 on 09-jan-2019.Additional information (08-jan-2019): a siemens field application specialist (fas) was dispatched to the customer's site and verified that a new bottle of sodium chloride was installed every day.The fas performed a comparison study on quality controls (qcs), calibration, and patient samples using the fib and fib.Low assay protocols; the fib.Low assay protocol is a method offered by siemens for determining low fibrinogen concentration.The qcs recovery, calibration curve and precision between replicates recovered within acceptable ranges; differences in fibrinogen results were obtained on 3 patient samples, but siemens determined that this was caused by sample specific issues.The customer indicated that all prothrombin time (pt), pt %, and pt international normalized ratio (inr) results were reported to the physician(s).Siemens further investigated the issue and determined that the assay protocol (fib low570) used to obtain the discordant result was a user defined method (udm).The fib.Low assay protocol was not utilized to test samples from this patient.Siemens determined the fib low570 assay protocol uses the same parameters as the fib.Low assay protocol, except the wavelength is 570 nm, instead of 405 nm.This should not be done without changing other parameters of the application, and the use of the udm assay protocol potentially contributed to the discordant fibrinogen result.The method code, result code and conclusion code was updated to reflect the additional information.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2019-00005_s1 was filed for the same issue.

• Brand Name: BCS XP SYSTEM
• Type of Device: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8233521
• MDR Text Key: 134193025
• Report Number: 9610806-2019-00004
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• PMA/PMN Number: K970431
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10461894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR