Catalog Number 367885 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/20/2023 |
Event Type
Injury
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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.
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Event Description
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It was reported when using the bd vacutainer® lh 102 i.U.Plus blood collection tubes have false troponin level results.The following information was provided by the initial reporter.The customer stated: our troponin false results have escalated again! please could we put some dates in the diary to do the training i don¿t think i can wait for the departments to get back to me as this is more urgent now.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos for evaluation for the unknown lot.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.The unknown lot was unable to be tested.This complaint is unable to be confirmed for erroneous results-troponin t for unknown lot.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Factors that may contribute to erroneous results were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.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 when using the bd vacutainer® lh 102 i.U.Plus blood collection tubes have false troponin level results.The following information was provided by the initial reporter.The customer stated: our troponin false results have escalated again! please could we put some dates in the diary to do the training i don¿t think i can wait for the departments to get back to me as this is more urgent now.
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Search Alerts/Recalls
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