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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿; COUNTER, DIFFERENTIAL CELL
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿; COUNTER, DIFFERENTIAL CELL Back to Search Results
Catalog Number 343202
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2022
Event Type  malfunction  
Event Description
It was reported that while using the bd facscalibur¿ that the customer is receiving erroneous results.The following information was provided by the initial reporter: the client comments that the results are not reliable, the instrument reads very fast.The client washed with hot water and against, it does not work.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that while using the bd facscalibur¿ that the customer is receiving erroneous results.The following information was provided by the initial reporter: the client comments that the results are not reliable, the instrument reads very fast.The client washed with hot water and against, it does not work.
 
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 and serial # (b)(6).Problem statement: customer reported a complaint regarding erroneous results on 26oct2022.The customer reported that the results are not reliable and the instrument reads very fast.This poses the risk of producing erroneous results that might impact patient diagnosis and treatment.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 26oct2021 to 26oct2022.¿ 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: there are 3 complaints related to erroneous diagnostic results; date range from 26oct2021 to 26oct2022.¿ returned sample analysis: a return sample was not requested because no parts were replaced.¿ service history review: review of related work order #: (b)(4).Install date: 21jul2014.Defective part number: n/a.Work order notes: subject / reported: 343202 - facscalibur 4 clr basic sensor unit - resultados erroneos problem description: the client comments that the results are not reliable, the instrument reads very fast.The client washed with hot water and against, does not smoke.Work performed : red laser compensation adjustment, customer processes calibrate and parameters are within ranges, works with samples without incident.The system remains operational and functioning.¿ cause: red laser compensation adjustment, customer processes calibrate and parameters are within ranges, works with samples without incident.The system remains operational and functioning.¿ solution: red laser compensation adjustment, customer processes calibrate and parameters are within ranges, works with samples without incident.The system remains operational and functioning.¿ parts replaced: n/a.¿ labeling / packaging review: n/a.¿ risk analysis: risk management file part # 342973ra, rev.04/vers.D, risk analysis facscalibur prod family was reviewed.This file did not contain the appropriate hazards and mitigations, and an eco has been opened to assess additional hazards and their risk levels.Ecr #(b)(4) has been created and will revise the existing calibur risk analysis document to include causes, mitigations, and risk ratings for erroneous results.¿ potential causes: based on the investigation results, the potential cause was an alignment or calibration issue of the red laser.¿ investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review.Based on the investigation results, the potential cause was an alignment or calibration issue of the red laser.The customer reported a complaint regarding erroneous results.The customer stated that the results are not reliable and that the instruments read very fast.In an attempt to resolve the issue, the field service representative (fsr) adjusted the red laser compensation.After the work performed, the instrument was tested and was functioning as expected.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.Neither the customer nor any patients were harmed due to this issue.¿ conclusion: based on the investigation results, complaint was confirmed and the potential cause was an alignment or calibration issue of the red laser.The customer reported a complaint regarding erroneous results.In an attempt to resolve the issue, the field service representative (fsr) adjusted the red laser compensation.After the work performed, the instrument was tested and was functioning as expected.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.¿ supporting document: n/a.
 
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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 Key15710943
MDR Text Key303307854
Report Number2916837-2022-00326
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K973483
Number of Events Reported1
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 03/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number343202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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