Model Number 340486 |
Device Problem
Low Readings (2460)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 while testing with bd calibrite¿ 3 beads there was a poor fl3 performance.Confirmatory testing performed running test simultaneously on to rule out machine issue.New lot of beads passed.The following information was provided by the initial reporter: nature of incident: poor fl3 performance.The affected calibrite bead lot number is 0002577 tested same calibrite bead on 2 unit facscalibur simultaneously (machine a & machine b) to rule out machine problem.Run facscomp using different lot of calibrite bead #0212458 and it show pass.
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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# 2916837-2021-00040 was sent in error.There were no patient samples involved, and reagent lot-to-lot variation is not considered to be a reportable malfunction.
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Event Description
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It was reported while testing with bd calibrite¿ 3 beads there was a poor fl3 performance.Confirmatory testing performed running test simultaneously on to rule out machine issue.New lot of beads passed.The following information was provided by the initial reporter: nature of incident: poor fl3 performance.The affected calibrite bead lot number is 0002577.Tested same calibrite bead on 2 unit facscalibur simultaneously (machine a & machine b) to rule out machine problem.Run facscomp using different lot of calibrite bead #0212458 and it show pass.
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Search Alerts/Recalls
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