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

Model Number BCS XP SYSTEM

Device Problem Mechanical Problem (1384)

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

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics (siemens) customer service engineer (cse) was dispatched to the customer's site to determine the cause of the discordant, falsely elevated fibrinogen result on the bcs xp system.The cse adjusted the optics and replaced the lamp, sample probe and the 405 nm and 570 nm filters.The cse also ran a validation kit and quality controls, which recovered within expected ranges.Siemens discussed sample handling techniques with the operator and determined that the operator is handling samples according to the instruction for use (ifu).The operator stated that after obtaining the discordant fibrinogen result on the bcs xp system, the system produced a flag, on the next sample run, to indicate low reagent.The operator replaced the reagent and reran the patient sample, which resulted within expected ranges.The cause of the event is unknown.The system and reagent are performing according to specifications.No further evaluation of this system is required.

Event Description

Non-numerical, flagged fibrinogen results of "no reaction" were obtained on a patient sample on two bcs xp systems.None of these results were reported to the physician(s).The same sample was reflexed to the fib570 assay and rerun on both systems.While the bcs xp system with serial number (b)(4) flagged the repeat result with "result doubtful", "no reaction" and "measurement curve without reaction", the other bcs xp system with sn (b)(4) produced a discordant, falsely elevated fibrinogen result.This result was auto-filed to the laboratory information system (lis) and reported to the physician(s), who did not question the result.The operator changed the reagent vial on the system with sn (b)(4) and reran the same sample, resulting lower.The same sample was also rerun on the other system with sn (b)(4), resulting lower than the discordant result.As per the lab's policy, the operator amended the fibrinogen result to "<80 mg/dl" to the lis and reported this result to the physician(s).The lower fibrinogen results aligned with the patient's clinical history and condition.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated fibrinogen result.

Manufacturer Narrative

Siemens healthcare diagnostics (siemens) filed the initial mdr 9610806-2017-00152 on 28-dec-2017.Additional information (04-jan-2018): a siemens headquarters support center (hsc) specialist analyzed the bcs xp system's back up files to determine the cause of the discordant, falsely elevated fibrinogen result.The hsc specialist determined that the operator is using a siemens validated application for the fibrinogen assay and quality controls (qcs) recovered within expected ranges prior to and after obtaining the discordant result.The hsc specialist also determined that sample (b)(6) was the only sample affected by the event and that there is no indication of a reagent issue.The hsc specialist's analysis of the data logs determined that inadequate aspiration of reagent volume and patient sample resulted in a clot and potentially contributed to the discordant, falsely elevated fibrinogen result.

• 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: 7152256
• MDR Text Key: 96232139
• Report Number: 9610806-2017-00152
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 10459330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1