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 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

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 ce-ivd flow cytometer customer noticed different results when comparing the samples prepared with the duet and the enumeration they make.There was no report of patient impact.The following information was provided by the initial reporter: customer noticed different results when comparing the samples prepared with the duet and the enumeration they make.With the duet, the results are higher than expected.Was it obvious that the results were erroneous/could not be trusted? yes.Is it standard procedure to test the samples both on duet and enumeration? yes.If not, why did they do it in this case? -- were patient samples involved? yes.If yes, were any erroneous results reported to the clinician? no.

Manufacturer Narrative

H.6 investigation summary investigation summary: include all elements under the investigation summary.Scope of issue: the scope of issue is limited to part: 662588 and serial#: (b)(6) problem statement: erroneous result.Customer noticed different results when comparing the samples prepared with the duet and the enumeration they make.With the duet, the results are higher than expected.They then tested the sampling and noticed that more volume is withdrew (about 52ul instead of 50ul).Customer has verified that there is no leak behind the side panel.6 months maintenance was done on june 13 and the instrument worked fine after that.Manufacturing defect trend: there are no qns related to the reported issue.Date range (date of incident to 12 months back) from 07/04/2021 to date 07/04/2022 related qn(s) number: n/a.Device history record (dhr) review: dhr part#: 662588, serial#: (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: there is another complaint related to the reported complaints.Date range (date of incident to 12 months back) from 07/04/2021 to 07/04/2022.Returned sample analysis: the complaint sample was not requested to be returned because the part is not returnable.Service history review: wo reviewed: (b)(4).Install date: on (b)(6) 2020.Work order notes: changing the sampling needle.Changing the syringe/valve assembly.Changing the tubes of the peristaltic cassette.Function test ok.Controller conforms to manufacturer's specifications.Customer to contact tomorrow for follow-up.Return customer by email: ok.Cause: loose syringe.Solution: changing the syringe/valve assembly.Labeling /packaging review: (if applicable) n/a.Risk analysis: 0 risk management file part#: 10000225098ra, revision 01 was reviewed.Hazard(s) identified? yes.Hazard id#: (b)(4).Hazard: insufficient specimen volume.Cause: probe does not aspirate enough volume for test.Harmful effects: incorrect result.Residual severity: 3.Residual probability: 1.Residual risk index: 3.Root cause: 0 based on the investigation result, the root cause was determined to be pm components ¿ syringe/valve assembly.Conclusion: based on the investigation results, complaint was confirmed.This is not a standard practice to compare enumeration with facsduet result.The pm components was replaced and an accuracy and precision test was performed and passed.Sa, pssa, capa, scar reference, (if applicable): n/a.Based on the investigation a capa is not required.

Event Description

It was reported that while using bd facsduet sample prep ce-ivd flow cytometer customer noticed different results when comparing the samples prepared with the duet and the enumeration they make.There was no report of patient impact.The following information was provided by the initial reporter: customer noticed different results when comparing the samples prepared with the duet and the enumeration they make.With the duet, the results are higher than expected.Was it obvious that the results were erroneous/could not be trusted? yes is it standard procedure to test the samples both on duet and enumeration? yes if not, why did they do it in this case? were patient samples involved? yes.If yes, were any erroneous results reported to the clinician? no.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15210465
• MDR Text Key: 303561545
• Report Number: 2916837-2022-00212
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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: Health Professional
• Device Catalogue Number: 662588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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