MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LWA; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number 337408

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

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported that erroneous results were observed on patient samples during use with the bd facs¿ lwa.The following information was provided by the initial reporter: 1.Are there erroneous results on patient samples from diagnostic test?(if yes or unknown, go to question #2.If no, no further questions required): yes.Samples had some carryover but not enough to affect the patient samples in a negative manner.It was reported by the customer that not performing lyse wash on samples.Spoke with customer and they are getting very different results on their lwas.This one does not appear to be lyse washing the samples.

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 erroneous results were observed on patient samples during use with the bd facs¿ lwa.The following information was provided by the initial reporter: 1.Are there erroneous results on patient samples from diagnostic test?(if yes or unknown, go to question #2.If no, no further questions required): yes.Samples had some carryover but not enough to affect the patient samples in a negative manner.It was reported by the customer that not performing lyse wash on samples.Spoke with customer and they are getting very different results on their lwas.This one does not appear to be lyse washing the samples.

Manufacturer Narrative

The following fields have been updated with corrected information: g.1 - reporting office contact - (b)(6).G.1 - manufacturing site contact - (b)(6).G.1 - reporting office- becton dickinson and company bd biosciences.H6.Investigation summary: based on the investigation results, the reported issue 'not performing lyse wash on samples' was 'confirmed' and the potential cause was determined to be worn out cell wash assembly.Investigation results were performed on the review of the complaint trend, defect trend, dhr, risk analysis and service activity review.The fse replaced the part and after subsequent testing, the instrument was functioning as expected.No one was harmed or injured, and no patients were diagnosed or treated based on any unexpected results.The safety risk of this hazard has been identified to be within the acceptable level.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 FACS¿ LWA
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• 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: 17769534
• MDR Text Key: 323819103
• Report Number: 2916837-2023-00184
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 337408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/18/2023
• 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: 05/14/2020
• 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