MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H.10

Catalog Number 647205

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

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

D2a:common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.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 bd facs¿ sample prep assistant iii has accuracy issues occurring.The following information was provided by the initial reporter: accuracy issues.They have rebooted the instrument and computer.No change 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? no.4.Was there any physical harm/injury to the patient due to the issue? no.

Manufacturer Narrative

The following fields have been updated with corrected information: g.1 - reporting office contact - (b)(6).G1.Reporting office - becton dickinson and company bd biosciences investigation summary: based on the review of the complaint trend, defect trend, dhr, risk analysis and service max activity, the reported 'accuracy issue' was not confirmed.The potential cause was not determined.The fse checked the system operation, verified sample volume with a&p test.The system was initialized and functions properly without error.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 bd facs¿ sample prep assistant iii has accuracy issues occurring.The following information was provided by the initial reporter: accuracy issues.They have rebooted the instrument and computer.No change 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? no 4.Was there any physical harm/injury to the patient due to the issue? no.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Type of Device: SEE H.10
• 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: 18130721
• MDR Text Key: 328284620
• Report Number: 2916837-2023-00219
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131301
• 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: 03/16/2024

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: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 03/16/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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