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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 342973
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that during use with a bd facscalibur flow cytometer there was an error message during run with patient samples, however, the samples were able to be fully processed.There was no reported patient impact.The following information was provided by the initial reporter: communication was made with the user and suggestions were made to launch the program again.The ërror program¨ message appeared at the end of running the samples, but the sample was processed.¿ additionally, on 2020-9/15 2020 the fse provided the following additional information: was there any impact to the patient(s)? no.Were samples redrawn? no.Was there any delay in treatment? no.The run was with patient samples.The equipment is used for clinical tests.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00163 was sent in error.Error message produced no results on patient samples, therefore this is not considered to be a reportable malfunction.
 
Event Description
It was reported that during use with a bd facscalibur flow cytometer there was an error message during run with patient samples, however, the samples were able to be fully processed.There was no reported patient impact.The following information was provided by the initial reporter: communication was made with the user and suggestions were made to launch the program again.The ërror program¨ message appeared at the end of running the samples, but the sample was processed.¿ additionally, on (b)(6) 2020 the fse provided the following additional information: was there any impact to the patient(s)? no.Were samples redrawn? no.Was there any delay in treatment? no.The run was with patient samples.The equipment is used for clinical tests.
 
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Brand Name
BD FACSCALIBUR FLOW CYTOMETER
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
MDR Report Key10639522
MDR Text Key212084647
Report Number2916837-2020-00163
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903429738
UDI-Public00382903429738
Combination Product (y/n)N
PMA/PMN Number
K973483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/02/2021
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 Number342973
Device Catalogue Number342973
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/15/2020
Initial Date FDA Received10/06/2020
Supplement Dates Manufacturer Received09/15/2020
Supplement Dates FDA Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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