CUE HEALTH INC. CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
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Model Number C2020 |
Device Problem
False Negative Result (1225)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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Customer reports individual received eleven false negative results when testing with the cue covid-19 test for home and over the counter (otc) use.This case is to document one of the false negative results obtained.See related cases for alternate false negative results.Customer reports individual received a potential 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 18959f, reader sn (b)(4)).No alternate testing performed for this cue covid-19 test.Individual confirmed they had known exposure from someone in their home and cartridges were stored within the validated temperature range.Customer was experiencing mild symptoms on (b)(6) 2022.
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Search Alerts/Recalls
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