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

Model Number 647205

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

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs¿ sample prep assistant iii erroneous results occurred.The following information was provided by the initial reporter erroneous results occurring.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.

Manufacturer Narrative

H.6 investigation summary (b)(4), pn: 647205, spaiii, sn:(b)(6).Date reported: 09/19/2022.Investigation summary: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: erroneous results.Manufacturing defect trend: there are (b)(4) qns related to the reported issue.Date range (date of incident to 12 months back) from 19sep2021 to date 19sep2022 (rolling 12 months).Complaint trend: there are (b)(4) complaints related to the reported complaint.Date range (date of incident to 12 months back) from 19sep2021 to date 19sep2022 (rolling 12 months) (b)(4) (this complaint).Investigation result / analysis: per customer¿s report: customer reported that several of the patient samples needed to be rerun on the spa due to the unexpected results that were observed.However, none of the unexpected results were reported and there was no delay in reporting the results.Samples were rerun, and the correct results were sent out.Service max review: review of related work order#: work order was not created for this complaint install date: (b)(6) 2019.Defective part number: there were no defective parts.Returned sample analysis: the complaint sample was not requested to be returned and no photo(s) / picture(s) were provided.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes no.Hazard id: 3.1.20.Hazard: ineffective sample prep.Cause: probe dripping, leading to sample carryover.Harmful effects: contaminated sample prep.Residual severity: 3.Residual probability: 1.Residual risk index: 3.Root cause: based on the investigation result and the root cause cannot be determined.Conclusion: based on the investigation results and the call report the complaint was unconfirmed.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.

Event Description

It was reported that while using bd facs¿ sample prep assistant iii erroneous results occurred.The following information was provided by the initial reporter erroneous results occurring.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15473788
• MDR Text Key: 305149659
• Report Number: 2916837-2022-00264
• Device Sequence Number: 1
• Product Code: PER
• 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: 12/23/2022

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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