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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
Catalog Number 1001-0622
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 12/06/2023
Event Type  malfunction  
Event Description
The consumer called oti consumer support stating they tested negative using inteliswab but tested positive when they retested right after.The consumer did not state if the second test was an inteliswab test or a different brand or if a pcr test was taken to confirm the false negative inteliswab test results.The consumer did not provide any product information.The consumer also did not provide a phone number or email address for a follow-up.
 
Manufacturer Narrative
12/14/2023 correction: inteliswab lot number 0006707574 was provided by the consumer.Description of event, catalog #, lot #, expiration date, and device manufacture date fields updated.The consumer reported false negative inteliswab test results but did not state if a confirmatory pcr test was performed.The consumer did not provide a phone number or email address for oti to perform a follow up.No additional follow up is to be expected with this complaint and the incident will be closed internally.
 
Event Description
The consumer called oti consumer support stating they tested negative using inteliswab but tested positive when they retested right after.The consumer did not state if the second test was an inteliswab test or a different brand or if a pcr test was taken to confirm the false negative inteliswab test results.The consumer did not provide a phone number or email address for a follow-up.
 
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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 Key18283312
MDR Text Key329947655
Report Number3004142665-2023-00046
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 12/14/2023
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
Device Catalogue Number1001-0622
Device Lot Number0006707574
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/06/2023
Initial Date FDA Received12/07/2023
Supplement Dates Manufacturer Received12/06/2023
Supplement Dates FDA Received12/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2023
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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