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 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: na.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 while using the bd facs¿ lwa.The following information was provided by the initial reporter: mdr safety checklist - patient samples (case).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.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? not applicable.4.Was there any physical harm/injury to the patient due to the issue? no.5.Provide details - how and to what extent? they reran sample on a different instrument.Whether carryover happened on patient samples? there was no carry over.It was reported by the customer that system is having problems washing samples on specific program.

Manufacturer Narrative

The following fields have been updated: g.1.Reporting office: becton dickinson and company bd biosciences g.2.Reporting office contact: (b)(6).Investigation summary: based on the review of the complaint trend, defect trend, dhr, risk analysis and service activity review the complaint was confirmed, and the potential cause of the unexpected results was determined to be worn out cell wash assembly and v3.The fse replaced the parts 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.

Event Description

It was reported that erroneous results were observed while using the bd facs¿ lwa.The following information was provided by the initial reporter: mdr safety checklist - patient samples (case) 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 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? not applicable 4.Was there any physical harm/injury to the patient due to the issue? no 5.Provide details - how and to what extent? they reran sample on a different instrument whether carryover happened on patient samples? there was no carry over it was reported by the customer that system is having problems washing samples on specific program.

• 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: 18066619
• MDR Text Key: 327303051
• Report Number: 2916837-2023-00214
• 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: 10/23/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/21/2024
• 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