Model Number 367815 |
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 12/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.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 discrepant results were observed on the bd red top tubes and the gold top sst.Verbatim: we ran a small study comparing iron studies between bd red top tubes and the gold top sst on our ortho diagnostics vitros 5600.One patient known to be taking medication for thyroid showed variation.No confirmatory testing was performed.No erroneous results were reported.We were just trying to determine if there would be a difference between the two tubes and we confirmed that there could be.
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Manufacturer Narrative
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The following field has been updated with corrected information: b.5.Describe event or problem: it was reported that discrepant results were observed on the bd vacutainer® serum blood collection tubes.Confirmatory testing was not completed and there was no patient impact.The following information was provided by the initial reporter: we ran a small study comparing iron studies between bd red top tubes on our ortho diagnostics vitros 5600.One patient known to be taking medication for thyroid showed variation.No confirmatory testing was performed.No erroneous results were reported.We were just trying to determine if there would be a difference between the two tubes and we confirmed that there could be.H.6.Investigation summary: bd had not received samples or photos 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.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.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 discrepant results were observed on the bd vacutainer® serum blood collection tubes.Confirmatory testing was not completed and there was no patient impact.The following information was provided by the initial reporter: we ran a small study comparing iron studies between bd red top tubes on our ortho diagnostics vitros 5600.One patient known to be taking medication for thyroid showed variation.No confirmatory testing was performed.No erroneous results were reported.We were just trying to determine if there would be a difference between the two tubes and we confirmed that there could be.
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Search Alerts/Recalls
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