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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 338960
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
It was reported that bd facscanto¿ ii flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: "experimental results are abnormal.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue ? no.If patient samplers were redrawn, was there any change or delay of treatment ? no.Was there any physical harm/injury to the patient due to the issue? no".
 
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 bd facscanto¿ ii flow cytometer acquired erroneous results on patient samples.The following information was provided by the initial reporter: "experimental results are abnormal.Are there erroneous results on patient samples from diagnostic test? yes.Was there any delay of treatment due to the issue ? no.If patient samplers were redrawn, was there any change or delay of treatment ? no.Was there any physical harm/injury to the patient due to the issue? no".
 
Manufacturer Narrative
H6: investigation summary scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2 system ivd, part # 338960, and serial # (b)(6).Problem statement: customer reported a complaint regarding the instrument producing erroneous results.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 15dec2020 to date 15dec2021.Complaint trend: there are 16 complaints related to this issue of erroneous results.Date range from 15dec2020 to date 15dec2021.Manufacturing device history record (dhr) review: dhr part # 338960 serial # (b)(4), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.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 erroneous results was due to a worn fiber.The customer had initially reported that this instrument was producing erroneous results, and it was discovered in (b)(4) that the cause was a worn 488 fiber.The customer eventually refused the quote for the repair and the case was closed.No parts were requested for evaluation as there were no replaced parts.Although the instrument was used for diagnostic testing the issue was identified and resolved before the patient sample results were used for any diagnosis or treatment.Cleaning the fluidics and regular maintenance is essential for keeping the instrument at its optimal performance.This information can be found in the bd facscanto¿ ii flow cytometer instructions for use (ifu) manual, #23-20269-00 rev.1/vers.A.The safety risk of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #: (b)(4).Install date: 01jul2016.Defective part number: n/a.Work order notes: subject / reported: (b)(4)/facscanto ii-experimental results are abnormal.Problem description: facscanto ii experiment results are abnormal, clinical use, not applied to patient treatment, (b)(6).Work order notes: (12/14/2021 11:59 pm) engineer feedback: the instrument fiber is faulty (b)(4), and the abnormal experimental result is caused by the fault, and the customer refuses to pay for repairs.(12/14/2021 11:57 pm) engineer feedback: the instrument fiber is faulty (b)(4), and the customer refuses to pay for repairs.((b)(6) 2021 5:16 pm) facscanto ii experiment results are abnormal, clinical use, not applied to patient treatment, (b)(6).Returned sample evaluation: a return sample was not requested because there were no replaced parts.Risk analysis: risk management file facscanto ii flow cytometer (optics) #338960-05ra (version a/revision 2) was reviewed and identified the cause of a faulty optical fiber.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes, no.Item: 5.Optical fiber: function: 5.1 maintains laser polarization, potential failure mode: 5.1.1 reduced laser power, potential effects of failure: 5.1.1.2 cvs out of spec, potential causes/mechanisms of failure: 5.1.1.1.2 low or varying power due to misalignment, current controls: setup voltages change, recommended actions: n/a, responsible party: n/a, target completion date: n/a, actions taken: n/a, sev: 4, occ: 4, det: 4, rpn: 64.Item: 5.Optical fiber: function: 5.2 delivers laser beam to optics plate, potential failure mode: 5.2.1 signal varies, potential effects of failure: 5.2 1.1 events misclassified, potential causes/mechanisms of failure: 5.2.1.1.1 fiber out of spec, current controls: fiber inspection, recommended actions: n/a, responsible party: n/a, target completion date: n/a, actions taken: n/a, sev: 8, occ: 2, det: 1, rpn: 16.Mitigation(s) sufficient: yes, no.Root cause: based on the investigation results the root cause of the erroneous results was due to a worn fiber.Conclusion: based on the investigation results the root cause of the erroneous results was due to a worn fiber.The cause of the erroneous results was discovered in (b)(4) to be due to a 488 fiber with lower power.The repair ultimately was not performed as the customer rejected the quote for repair and the case was closed.No treatment or diagnosis was given due to the unexpected results.The safety risk of this hazard has been identified to be within the acceptable level.H3 other text : see h10.
 
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Brand Name
BD FACSCANTO¿ II FLOW CYTOMETER
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 Key13047439
MDR Text Key284018535
Report Number2916837-2021-00493
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903389605
UDI-Public00382903389605
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K062087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number338960
Device Catalogue Number338960
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
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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