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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 Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 03/12/2024
Event Type  malfunction  
Event Description
A consumer posted on twitter stating, 'i'm absolutely shocked that i tested +ve for the 1st time ever today, especially since i've been isolated for a month + always wear an aura outside my apt.Negative on lucira, cue + some off-brand free gov rat.Pos on expired inteliswab.' refer to the attached twitter comment.
 
Manufacturer Narrative
The consumer posted on twitter stating they received false positive test results using an expired inteliswab test.Specific details of the collection and testing process of the inteliswab test was not provided.The consumer also did not provide a lot number to confirm whether this lot's expiration date was extended or was confirmed expired.The consumer stated they tested negative on other brand rapid tests, but it is unknown if a pcr test was taken to confirm the test results.Orasure technologies, inc.Is unable to contact the consumer for additional information as no contact information is available on twitter.No additional follow up is to be expected with this complaint and the incident will be closed internally.
 
Event Description
A consumer posted on twitter stating, 'i'm absolutely shocked that i tested +ve for the 1st time ever today, especially since i've been isolated for a month + always wear an aura outside my apt.Negative on lucira, cue + some off-brand free gov rat.Pos on expired inteliswab.
 
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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 Key18887866
MDR Text Key337529935
Report Number3004142665-2024-00008
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 Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received03/12/2024
Supplement Dates Manufacturer Received03/12/2024
Supplement Dates FDA Received04/11/2024
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 Unknown
Patient Sequence Number1
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