MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR

Catalog Number 343023

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

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using bd facscalibur¿ for research purposes there was erroneous results obtained in visualization of the signals.The following information was provided by the initial reporter: sample reading failure.1.- this instrument is a research instrument.So no patients are involved.They work with animal samples.2.- the erroneous results were related to a small distortion in the visualization of the signals.3.- this client does not have any type of quality control called calibration beads or any brand control.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00267 was sent in error.Testing performed was for research only, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd facscalibur¿ for research purposes there was erroneous results obtained in visualization of the signals.The following information was provided by the initial reporter: sample reading failure.1.This instrument is a research instrument.So no patients are involved.They work with animal samples.2.The erroneous results were related to a small distortion in the visualization of the signals.3.This client does not have any type of quality control called calibration beads or any brand control.

• Brand Name: BD FACSCALIBUR
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10878187
• MDR Text Key: 218521539
• Report Number: 2916837-2020-00267
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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
• Device Operator: Other
• Device Catalogue Number: 343023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1