Device Problem
False Negative Result (1225)
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Patient Problem
Viral Infection (2248)
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Event Date 08/12/2022 |
Event Type
malfunction
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Event Description
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Consumer reported to the call center that he used the first test in his inteliswab test kit and received a negative result.Consumer waited a couple more days and took the second test in the test kit and received another negative result.The consumer was feeling unwell and had a pcr test performed.The pcr test result was positive.After the consumers positive pcr test result, he waited a few days and tested again with inteliswab.Inteliswab test results were negative.The consumer could not provide a lot or material number of his test kit.
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Manufacturer Narrative
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Consumer notified the call center of the false negative results.No additional follow up is to be expected with the complaint file and the incident will be closed internally.
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Event Description
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Consumer reported to the call center that he used the first test in his inteliswab test kit and received a negative result.Consumer waited a couple more days and took the second test in the test kit and received another negative result.The consumer was feeling unwell and had a pcr test performed.The pcr test result was positive.After the consumers positive pcr test result, he waited a few days and tested again with inteliswab.Inteliswab test results were negative.The consumer could not provide a lot or material number of his test kit.
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Search Alerts/Recalls
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