Customer reports four false negative results when testing with the cue covid-19 test for home and over the counter (otc) use.This report is to document one of the four false negative results.See related cases for alternate false negative results.Customer reports receiving a false negative result on (b)(6) 2022 when testing with the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4), lot 20241d, reader sn (b)(4).Customer tested positive on (b)(6) 2022 with an unspecified rapid antigen test.Customer states they have continued to test positive with rapid antigen tests since but did not provide exact frequency or dates.Customer experiencing severe symptoms of coughing, fever and shortness of breath since the previous monday.Cartridges stored within the validated temperature range.
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Explanation for device evaluated by mfr: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false negative tests and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were three similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.A technical support representative reviewed customer data and performed data analysis.All data values were normal and met acceptable criteria.Root cause was undetermined.
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