Model Number 338960 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2020 |
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 while using bd facscanto¿ ii flow cytometer the patient samples were contaminated due to foreign matter clogging instrument.The following information was provided by the initial reporter, translated from (b)(6) to english: unit 4 is slightly clogged and the sample pattern is bad.Please confirm the safety check below.Were samples contaminated? yes.Was testing performed on patient samples intended for clinical use? yes.Are there erroneous results on patient samples from diagnostic test? no.
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Event Description
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It was reported that while using bd facscanto¿ ii flow cytometer the patient samples were contaminated due to foreign matter clogging instrument.The following information was provided by the initial reporter, translated from japanese to english: unit 4 is slightly clogged and the sample pattern is bad.Please confirm the safety check below.1.Were samples contaminated? yes.2.Was testing performed on patient samples intended for clinical use? yes.3.Are there erroneous results on patient samples from diagnostic test? no.
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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# 2916837-2020-00291 was sent in error.The sample that was contaminated was not a patient sample, therefore, this is not considered to be a reportable malfunction.
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Search Alerts/Recalls
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