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Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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On (b)(6) 2024, a consumer commented on a twitter post stating they are testing positive using inteliswab tests only when they swab their cheeks/back of throat.The consumer stated they tested negative on a pcr, flowflex, ihealth, and binax tests.On (b)(6) 2024, oti marketing department replied to the consumer's twitter comment advising they email oti so we can reach out to them directly for additional information.Refer to attached screenshot of the twitter comments.As stated in the inteliswab covid-19 rapid test ifu, 'important: swabbing the nostrils is critical for obtaining an accurate result.If you do not swab your nose, the device will produce a false negative result.'.
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Event Description
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On (b)(6) 2024, a consumer commented on a twitter post stating they are testing positive using inteliswab tests only when they swab their cheeks/back of throat.The consumer stated they tested negative on a pcr, flowflex, ihealth, and binax tests.On (b)(6) 2024, oti marketing department replied to the consumer's twitter comment advising they email oti so we can reach out to them directly for additional information.Refer to attached screenshot of the twitter comments.As stated in the inteliswab covid-19 rapid test ifu, 'important: swabbing the nostrils is critical for obtaining an accurate result.If you do not swab your nose, the device will produce a false negative result.'.
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Manufacturer Narrative
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The consumer commented on twitter reporting false positive inteliswab test results only while using the device against the ifu.Oti marketing responded to the consumer's twitter comment advising them to email more information to (b)(4).The consumer has not provided a lot number or any additional information to date.No additional follow up is to be expected with this complaint and the incident will be closed internally.
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Search Alerts/Recalls
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