MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 1CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-140
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024.Additional testing was performed on 2024 (b)(6) with a flowflex antigen self-test and generated a positive result.The consumer was symptomatic.The customer confirmed there was no patient harm due to the test results.
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
Event or Problem Description
The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on 06aug2024.Additional testing was performed on 07aug2024 with a flowflex antigen self-test and generated a positive result.The consumer was symptomatic.The customer confirmed there was no patient harm due to the test results.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 000809122c 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 195-140 / lot 000809122c and test base part number 195-430wjr / lot 809122.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 000809122c showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however, it could have possibly been related to the patient sample.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 1CT
• 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: 20039217
• Report Number: 1221359-2024-00568
• Device Sequence Number: 3075291
• Product Code: QKP
• UDI-Device Identifier: 00811877011477
• UDI-Public: 01008118770114771725091410000809122C
• 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): 09/10/2024

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: 09/14/2025
• Device Catalogue Number: 195-140
• Device Lot Number: 000809122C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White