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
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Response to device evaluated by manufacturer: 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 test and a member of the technical support group was able to perform data analysis.Investigation summary: the complaint history was reviewed and there were no previous 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 received a false positive result on (b)(6) 2022 using cue covid-19 test for home and over the counter (otc) use cartridge lot 22063l, cartridge serial number (b)(4), and cue reader serial number (b)(4).Following the false positive, the customer received two subsequent negative cue covid-19 test results.Additionally, the customer tested negative with two abbott binaxnow antigen tests on (b)(6) 2022.The customer reported no symptoms or known covid-19 exposures.The cartridges were stored according to the instructions for use.
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