MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 4CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-180
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024.The first test generated a negative result.The second test generated a positive result.Confirmation testing was not performed.Although requested, no additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
Fda udi : (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot: 228694 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-180/ lot: 228694 and test base part number 195-430wl/ 224821.The lot met the required release specifications.A review of the complaints reported false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 228694 showed that the complaint rate is 0.000358%.A review of the complaints reported false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot: 228694 showed that the complaint rate is 0.000179%.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however, it could have possibly been related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 4CT
• 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: 18908392
• Report Number: 1221359-2024-00270
• Device Sequence Number: 7589160
• Product Code: QKP
• UDI-Device Identifier: 00811877011729
• UDI-Public: 00811877011729
• 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
• Report Date (Section B): 03/14/2024

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 Expiration Date: 09/15/2024
• Device Catalogue Number: 195-180
• Device Lot Number: 228694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2023
• 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: Female