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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INTELISWAB COVID-19 RAPID TEST
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ORASURE TECHNOLOGIES INTELISWAB COVID-19 RAPID TEST Back to Search Results
Catalog Number 1001-0616
Device Problem False Negative Result (1225)
Patient Problems Headache (1880); Viral Infection (2248); Sore Throat (2396)
Event Date 01/06/2022
Event Type  malfunction  
Event Description
Consumer left a review on (b)(6) stating they tested negative with inteliswab and tested positive with a pcr test.(b)(6) review (b)(6) 2022.Woke up with body aches, head ache, sore throat.Took the test, it was negative.Took ibuprofen and went to work.6 1/2 hrs.Later when i got off work, went to my doctor to get a flu test.Flu test was negative, so she did another covid (lab) test.Calls me the next afternoon, and it was positive.I'm sure i have the omicron variant b/c i don't feel that bad.(b)(6).
 
Event Description
Consumer left a review on (b)(6) stating they tested negative with inteliswab and tested positive with a pcr test.(b)(6) review (b)(6) 2022.Woke up with body aches, head ache, sore throat.Took the test, it was negative.Took ibuprofen and went to work.6 1/2 hrs.Later when i got off work, went to my doctor to get a flu test.Flu test was negative, so she did another covid (lab) test.Calls me the next afternoon, and it was positive.I'm sure i have the omicron variant b/c i don't feel that bad.(b)(6).
 
Manufacturer Narrative
Consumer posted review on walmart.Com.No followup is to be expected with the complaint file and the incident will be closed internally.
 
Event Description
Consumer left a review on walmart.Com stating they tested negative with inteliswab and tested positive with a pcr test.Walmart.Com review (b)(6) 2022: woke up with body aches, head ache, sore throat.Took the test, it was negative.Took ibuprofen and went to work.6 1/2 hrs.Later when i got off work, went to my doctor to get a flu test.Flu test was negative, so she did another covid (lab) test.Calls me the next afternoon, and it was positive.I'm sure i have the omicron variant b/c i don't feel that bad.(b)(6).
 
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Brand Name
INTELISWAB COVID-19 RAPID TEST
Type of Device
INTELISWAB
Manufacturer (Section D)
ORASURE TECHNOLOGIES
220 east first street
bethlehem PA 18015
Manufacturer (Section G)
ORASURE TECHNOLOGIES
220 east first street
bethlehem PA 18015
Manufacturer Contact
jose rosado
220 east first street
bethlehem, PA 18015
6108821820
MDR Report Key13204824
MDR Text Key285755346
Report Number3004142665-2022-00007
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number1001-0616
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/10/2022
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
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