MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD FACSDUET¿ SAMPLE PREP

Catalog Number 662588

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter address 1: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd facsduet¿ sample prep produced erroneous results.There was no report of user impact.The following information was provided by the initial reporter: "inconsistency was found in the result (from the same patient) of the b lymphocyte, cd19, processed in facsduet and acquired in facslyric and the result of the b lymphocyte, cd20, processed manually and acquired in facslyric 003/004.I believe there was an error when pipetting the sample into the facsduet." "1.Are there erroneous results on patient samples from diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no".

Event Description

It was reported that while using bd facsduet¿ sample prep produced erroneous results.There was no report of user impact.The following information was provided by the initial reporter: "inconsistency was found in the result (from the same patient) of the b lymphocyte, cd19, processed in facsduet and acquired in facslyric and the result of the b lymphocyte, cd20, processed manually and acquired in facslyric 003/004.I believe there was an error when pipetting the sample into the facsduet." "1.Are there erroneous results on patient samples from diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no".

Manufacturer Narrative

H6.Investigation summary: based on the review of complaint trend, defect trend, dhr review, risk analysis, and service report review, the reported issue ¿pipetting failure¿ was confirmed, the potential cause for this issue was incorrect system configuration.Fse analyzed the equipment configuration, it was observed that the ¿skip initial mixing¿ option was enabled.The issue was resolved after disabling the option.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD FACSDUET¿ SAMPLE PREP
• Type of Device: NA
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18503995
• MDR Text Key: 332904408
• Report Number: 2916837-2023-00237
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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: 662588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1