BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL
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Model Number 342973 |
Device Problem
Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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).
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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