MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿; COUNTER, DIFFERENTIAL CELL

Catalog Number 343202

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

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facscalibur¿ that the instrument has an error with the populations.The following information was provided by the initial reporter: the client comments that the instrument has an error with the populations.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: scope of issue: the scope of issue is only limited to facscalibur 4 clr basic sensor unit, part # 343202, serial # (b)(6).Problem statement: customer reported a complaint regarding an error with populations.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue for part # 343202.Date range from 16sep2021 to date 16sep2022.Manufacturing device history record (dhr) review: dhr part #343202, serial # (b)(6) , file #(b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.Complaint history review: this is the only complaint related to erroneous diagnostic results for part # 343202; date range from 16sep2021 to date 16sep2022.Returned sample analysis: a return sample was not requested because the entire instrument was replaced and scrapped.Service history review: review of related work order #: (b)(4); case # (b)(4).Install date: (b)(6) 2011.Defective part number: n/a.Work order notes: subject / reported: 343202 - facscalibur 4 clr basic sensor unit - error con populaciones.Problem description: the client comments that the instrument has an error with the populations.Work performed: equipment is cleaned.The client starts working with the new facslyric and the current equipment is to be uninstalled.Cause: cleaning.Solution: cleaning.Labeling / packaging review: n/a.Risk analysis: risk management file part # 342973ra, rev.04/vers.D, bd facscalibur product family risk analysis was reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes or no? hazard id #: 3.1.5 operational hazard ¿ fl3 separation qc failure.Hazard: instrument parameters not optimized.Cause: cannot proceed with clinical results after qc failure.Harmful effects: poor separation and gates do not work as desired leading to wrong result.Residual probability: 1; residual severity: 3; residual risk index: 3.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis, and servicemax, the root cause of the population errors could not be determined.In response to the customer¿s complaint regarding population errors causing erroneous results, an fse (field service engineer) went onsite to investigate the issue and cleaned the optics pathways in the instrument.However, due to the calibur being in end-of-service, the issue was not investigated further and the calibur was de-installed and replaced by a facslyric instrument instead.The fse confirmed that the lyric was up and running and in use by the customer.No parts were requested for evaluation since the entire instrument was de-installed and scrapped.Although the unexpected results were from patient samples, the customer confirmed that no patient was treated or harmed from incorrect results.The safety risk of this hazard has been identified to be within the acceptable level.Root cause: based on the investigation results, the root cause could not be determined.Conclusion: based on the investigation results, the root cause of the population errors on the facscalibur causing the erroneous results could not be determined.The fse confirmed the issue and cleaned the optics pathways in the instrument.However, the issue was not investigated further because the calibur is in the end-of-service phase, and it was de-installed and replaced by a facslyric instrument.After the replacement, the lyric was functioning as expected and being used by the customer.No one was harmed or injured, and no medical diagnosis was performed due to the erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.Supporting document: n/a.

Event Description

It was reported that while using bd facscalibur¿ that the instrument has an error with the populations.The following information was provided by the initial reporter: the client comments that the instrument has an error with the populations.

• Brand Name: BD FACSCALIBUR¿
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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: 15522739
• MDR Text Key: 302076204
• Report Number: 2916837-2022-00273
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903432028
• UDI-Public: (01)00382903432028
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 343202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• 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