Catalog Number 647205 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that carryover was observed on patient samples during use with the bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: in "wo-03192403" it has been stated as "sample carryover in pipetting" as part of compliance review could you please answer the following safety questions 1.Was the carryover observed in patient samples? a: yes, it was observed in patient samples.System pipetting failure.
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Manufacturer Narrative
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D.2.Common device name:: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis d.4.Medical device expiration date: na.E.1.(b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields have been updated with corrected and/or additional information: reporting office contact: fahmy razak - mdr.Manufacturing site contact: fahmy razak - mdr.H.6: based on the investigation results, the reported issue "system pipetting failure" was confirmed.Investigation results that were performed on the indicated failure mode were the following: the device history record (dhr) was reviewed and the product met all manufacturing specifications prior to release.The potential cause was due to a misaligned probe which was replaced, and subsequent tests were carried out with no issues observed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that carryover was observed on patient samples during use with the bd facs¿ sample prep assistant iii.The following information was provided by the initial reporter: in "(b)(4)" it has been stated as "sample carryover in pipetting" as part of compliance review could you please answer the following safety questions 1.Was the carryover observed in patient samples? a: yes, it was observed in patient samples.System pipetting failure.
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Search Alerts/Recalls
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