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Catalog Number 762165 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
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Event Description
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It was reported when using the paxgene® blood rna tube customer reports that after centrifugation, no pellet is seen.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: per customer, description of tube photo: after the first centrifuge, the supernatant was discarded but we saved the tubes on friday.Today we added 400ul rnase-free water.After the centrifuge, we discarded the water and took the photo.Call activity comment: requested photo of sample post centrifugation, when no pellet is seen.
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Manufacturer Narrative
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H.6 investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for low yield was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Further clinical testing could not be conducted as the tubes were expired at the time of review.Clinical evaluation cannot be conducted on expired tubes.This complaint is unable to be confirmed for low yield.Bd was not able to identify a root cause for the indicated failure mode.A review of the ifu is recommended.H3 other text : see h.10.
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Event Description
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It was reported when using the paxgene® blood rna tube customer reports that after centrifugation, no pellet is seen.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: per customer, description of tube photo: after the first centrifuge, the supernatant was discarded but we saved the tubes on friday.Today we added 400ul rnase-free water.After the centrifuge, we discarded the water and took the photo.Call activity comment: requested photo of sample post centrifugation, when no pellet is seen.
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Search Alerts/Recalls
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