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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Catalog Number 195-160
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Manufacturer Narrative
Date of event provided in section b3 is an approximation, was not provided by consumer.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
 
Event Description
The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on an unknown date.Additional testing was performed on an unknown date with an unknown brand test (platform - unknown) which generated an unknown result.The customer stated the patient was sick but feeling better now.Although requested, no additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
Correction : g3 - date received by mfg - correct date received by manufacture is 07apr2024.It was inaccurate in initial report.Date of event provided in section b3 is an approximation, was not provided by consumer.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
 
Event Description
The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on an unknown date.Additional testing was performed on an unknown date with an unknown brand test (platform - unknown) which generated an unknown result.The customer stated the patient was sick but feeling better now.Although requested, no additional patient information, including treatment and outcome, was provided.
 
Event Description
The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on an unknown date.Additional testing was performed on an unknown date with an unknown brand test (platform - unknown) which generated an unknown result.The customer stated the patient was sick but feeling better now.Although requested, no additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
Date of event provided in section b3 is an approximation, was not provided by consumer.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend / unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
 
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Brand Name
BINAXNOW COVID-19 AG SELF TEST 2CT
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key19105426
MDR Text Key340348742
Report Number1221359-2024-00338
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/07/2024
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
Device Catalogue Number195-160
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/15/2024
Supplement Dates Manufacturer Received04/24/2024
05/01/2024
Supplement Dates FDA Received04/30/2024
05/07/2024
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 Initial
Patient Sequence Number1
Patient SexFemale
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