MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT II; STATION, PIPPETTING DILUTING CLINICAL

Catalog Number 337170

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

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 facs sample prep assistant ii carryover of samples occurred.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that the spa fails carryover test.Customer problem: spa fails carryover test.Steps taken with customer/troubleshooting: no troubleshooting performed.Next steps (if necessary): create case / wo and dispatch direct to fse.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Leak (if yes explain)? no.Software version? unknown.Resolution achieved (y/n)? unknown.Follow up required (y/n)? unknown.List of parts shipped (include foc): unknown.Rma required (y/n)? unknown.Is this a clinical or a research client? what instrument was used to perform the test? canto ii.Are the maintenance records up to date on the instrument? yes.How was the issue discovered? were erroneous results reported? cap survey.What type of specimen was it? bone marrow, peripheral blood? unknown.Was this a clinical specimen? yes.What testing was being performed? was this a standard leukemia/lymphoma panel? were there add-on tubes performed? unknown.Was the testing repeated or were the results confirmed? repeated.What was the diagnosis of the specimen tested prior to the specimen in question, and what was the cell count of the relevant cell population? unknown.What was the exact amount of carryover? how was this determined? plots.Are the dot plots from the analysis available for review? yes they are available.

Event Description

It was reported that while using bd facs sample prep assistant ii carryover of samples occurred.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that the spa fails carryover test.Customer problem: spa fails carryover test steps taken with customer/troubleshooting: no troubleshooting performed next steps (if necessary): create case / wo and dispatch direct to fse are you using this product for clinical diagnostic test? yes were erroneous results reported and used to treat a patient? no was there any injury or potential injury? no leak (if yes explain)? no software version? unknown resolution achieved (y/n)? unknown follow up required (y/n)? unknown list of parts shipped (include foc): unknown rma required (y/n)? unknown is this a clinical or a research client? what instrument was used to perform the test? canto ii are the maintenance records up to date on the instrument? yes how was the issue discovered? were erroneous results reported? cap survey what type of specimen was it? bone marrow, peripheral blood? unknown was this a clinical specimen? yes what testing was being performed? was this a standard leukemia/lymphoma panel? were there add-on tubes performed? unknown was the testing repeated or were the results confirmed? repeated what was the diagnosis of the specimen tested prior to the specimen in question, and what was the cell count of the relevant cell population? unknown what was the exact amount of carryover? how was this determined? plots are the dot plots from the analysis available for review? yes they are available.

Manufacturer Narrative

After further review mfr#2916837-2020-00245 is no longer reportable.This device is for research use only and is not being used for diagnostic testing or patient treatment and is therefore not subject to mdr reporting.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT II
• Type of Device: STATION, PIPPETTING DILUTING CLINICAL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10829459
• MDR Text Key: 215960423
• Report Number: 2916837-2020-00245
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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: 337170
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1