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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST
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ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST Back to Search Results
Device Problem False Negative Result (1225)
Patient Problem Viral Infection (2248)
Event Date 08/12/2022
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
INTELISWAB COVID-19 RAPID TEST
Type of Device
INTELISWAB
Manufacturer (Section D)
ORASURE TECHNOLOGIES, INC.
220 east first street
bethlehem PA 18015
Manufacturer (Section G)
ORASURE TECHNOLOGIES, INC.
220 east first street
bethlehem PA 18015
Manufacturer Contact
jennifer krause
220 east first street
bethlehem, PA 18015
6108821820
MDR Report Key15223927
MDR Text Key305347752
Report Number3004142665-2022-00025
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
PMA/PMN Number
EUA210378
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/12/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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