Catalog Number I-SRS-C-01 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Computer System Security Problem (2899)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2021 |
Event Type
malfunction
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Event Description
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User reported they hacked the bluetooth connection between the analyzer and the android app and switched a negative result to a positive result, and received a positive result certificate from third party proctoring service.
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Manufacturer Narrative
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Investigation not complete at time of initial report.Follow-up to be submitted upon completion of investigation.
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Manufacturer Narrative
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Report required by fda for eua.Investigation details were not available at the time of submission of initial report.Relevant investigation codes have been added to this final report.
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Event Description
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User reported they hacked the bluetooth connection between the analyzer and the android app and switched a negative result to a positive result, and received a positive result certificate from third party proctoring service.
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Search Alerts/Recalls
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