MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 10CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-170
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on an unknown date.The first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Initial testing was performed three (3) times using the binaxnow covid-19 antigen self-test kit, generating negative results.It is unclear if additional testing was performed.No additional information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
Additional Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided.The required intake 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.H3 other text : single use; device discarded.
Event or Problem Description
The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on an unknown date.The first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Initial testing was performed three (3) times using the binaxnow covid-19 antigen self-test kit, generating negative results.It is unclear if additional testing was performed.No additional information, including treatment and outcome, was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 10CT
• Common Device Name: 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 Key: 18352373
• Report Number: 1221359-2023-01779
• Device Sequence Number: 8415593
• Product Code: QKP
• UDI-Device Identifier: 00811877011118
• UDI-Public: 00811877011118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 195-170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown