Catalog Number 762165 |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that clotting occurred after use with a paxgene® blood rna tube.The following information was provided by the initial reporter, "customer called for tech support in regards to clotting of specimens.She does have unused tubes to be sent in for investigation.Rna testing was attempted but resulted in abnormally low results for rna.Customer is requesting tech support reach out to her for guidance.Comment type: work performed.Customer is collecting human blood into a sodium heparin tube and transferring to the paxgene rna tube with a syringe and needle.The blood is in the sodium heparin tube for about 24 hours before transferring.When transferred the blood is mixed 6-10 times in the paxgene tube.She states that the clots are pretty solid not microclots.She could not pipette out to do wash step.She does not know why it is happening in some tubes and not others.It is best to draw directly into paxgene tubes and not mix anticoagulant types." 4 occurrences were reported.
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Event Description
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It was reported that clotting occurred after use with a paxgene® blood rna tube.The following information was provided by the initial reporter, "customer called for tech support in regards to clotting of specimens.She does have unused tubes to be sent in for investigation.Rna testing was attempted but resulted in abnormally low results for rna.Customer is requesting tech support reach out to her for guidance.Comment type: work performed customer is collecting human blood into a sodim heparin tube and transferring to the paxgene rna tube with a syringe and needle.The blood is in the sodium heaprin tube for about 24 hours before transferring.When transferred the blood is mixed 6-10 times in the paxgene tube.She states that the clots are pretty solid not microclots.She could not pipette out to do wash step.She does not know why it is happening in some tubes and not others.It is best to draw directly into paxgene tubes and not mix anticoagulant types." 4 occurrences were reported.
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
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Search Alerts/Recalls
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