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 Positive Result (1227)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/15/2022 |
Event Type
malfunction
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Event Description
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Customer received a false positive result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 22515c, reader sn (b)(4)).Two repeat cue tests performed on (b)(6) 2022 provided negative results.On (b)(6)2022, customer tested negative with 2 antigen tests (brand unspecified) and a pcr test through curative.Customer reportedly had cold symptoms and no known exposure.
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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 positive tests and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there was one similar complaint 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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