Catalog Number 445003 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that while using bd sars-cov-2 reagents for bd max¿ system 8 false positive results, including a negative qc failure, were obtained by the laboratory personnel.The customer reviewed the sample curves and noticed they were atypical.The samples were repeated, and resulted as negative.No erroneous results were reported out, and there was no report of patient impact.
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Manufacturer Narrative
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The following fields were corrected with additional information: event description: it was reported that while using bd sars-cov-2 reagents for bd max¿ system a high level of false positive results were obtained by the laboratory personnel.The curves appeared irregular, and samples were repeated.The false results were not reported to the clinicians.
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Event Description
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It was reported that while using bd sars-cov-2 reagents for bd max¿ system a high level of false positive results were obtained by the laboratory personnel.The curves appeared irregular, and samples were repeated.The false results were not reported to the clinicians.
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Manufacturer Narrative
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(b)(4).Investigation summary: bd has received several customer complaints for weak n2 positive results, when using bd sars-cov-2 reagents for bd max¿ system.Most of these complaints concerned atypical curves, with low endpoints.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd max¿ system kits mixed with multiple lots of bd max¿ exk¿ tna-3 assay kits.Analysis of the various databases received from customers revealed evidence of similar patterns.All the runs analyzed showed presence of background noise caused by signal drift in the cy5 channel, with the n2 target causing an interruption in background correction, generating a steady increase of fluorescence in the curves, resulting in false positive results.In all cases, contributing factors included the instrument in combination with the user defined protocol (udp) programming and product design.The issue was reproduced internally at bd.Complaint verification showed a complaint trend on bd sars-cov-2 reagents for bd maxtm system lots for false positive results.The root cause is under investigation and will be documented in our quality system.Bd confirms the complaint based on the investigation that was performed.A corrective and preventive action (capa) is already initiated (pr# (b)(4)) to investigate the root cause and some mitigation actions are already being addressed.
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Event Description
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It was reported that while using bd sars-cov-2 reagents for bd max¿ system a high level of false positive results were obtained by the laboratory personnel.The curves appeared irregular, and samples were repeated.The false results were not reported to the clinicians.
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Search Alerts/Recalls
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