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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 11/22/2023
Event Type  malfunction  
Event Description
Consumer left an amazon review for inteliswab claiming false negative results.Amazon review: 'these suck i took 4 of these tests.3 negatives over several days and 1 with just nothing.I used a different test and it was positive.' the consumer received three false negative test results using three separate inteliswab devices.Refer to the below manufacturer report numbers for the additional false negative submissions: mdr # 3004142665-2023-00044 and mdr # 3004142665-2023-00045.
 
Manufacturer Narrative
The consumer reported false negative inteliswab test results in their amazon.Com review.Specific details of the collection and testing process of the inteliswab tests were not provided.The consumer also did not provide a lot number or any other product information.It is unknown if a pcr test was used to confirm the test results.Orasure technologies, inc.Is unable to contact the consumer for additional information as no contact information is available on amazon.Com.No additional follow up is to be expected with this complaint and the incident will be closed internally.
 
Event Description
Consumer left an amazon review for inteliswab claiming false negative results.Amazon review: 'these suck i took 4 of these tests.3 negatives over several days and 1 with just nothing.I used a different test and it was positive.' the consumer received three false negative test results using three separate inteliswab devices.Refer to the below manufacturer report numbers for the additional false negative submissions: mdr # 3004142665-2023-00044, mdr # 3004142665-2023-00045.
 
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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 Key18229104
MDR Text Key329460720
Report Number3004142665-2023-00043
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 12/06/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/27/2023
Initial Date FDA Received11/29/2023
Supplement Dates Manufacturer Received11/27/2023
Supplement Dates FDA Received12/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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