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	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
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 two false negative results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024.This manufacturer's report addresses test two (2) of two (2).Consumer performed two additional binaxnow covid-19 antigen self-tests on unknown dates and generated positive results.Additional testing was performed with the (b)(6) covid-19 test kit on (b)(6) 2024 and generated a positive result.The consumer was experiencing cough, sneezing and fever and contacted the doctor since he has copd which had the same symptoms as covid-19.The consumer was also taking paxlovid.The consumer confirmed there was no patient harm due to the test results.
Additional Manufacturer Narrative
Corrected data - b5 - describe event or problem | d4 - serial # testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 870976b 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 870976b and test base part number 195-430wjr/ lot 870976.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 870976b 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 possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.
Event or Problem Description
The consumer reported six false negative results with the binaxnow covid-19 antigen self-test performed on various dates.This manufacturer¿s report addresses patient 1 (qty 4), test two (2) of six of (6).The consumer performed a binaxnow covid-19 antigen self-test on (b)(6) 2024 and generated a negative result.Additional testing was performed with the(b)(6) on (b)(6) 2024 and generated a positive result.The consumer was experiencing cough, sneezing and fever and contacted the doctor since he has copd, which had the same symptoms as covid-19.The consumer was also taking paxlovid.The consumer confirmed there was no patient harm due to the test results.
Event or Problem Description
The consumer reported six false negative results with the binaxnow covid-19 antigen self-test performed on various dates.This manufacturer¿s report addresses patient 1 (test qty 4), test two (2) of six of (6).The consumer performed a binaxnow covid-19 antigen self-test on (b)(6) 2024 and generated a negative result.Additional testing was performed with the cvs covid-19 test kit on 03oct2024 and generated a positive result.The consumer was experiencing cough, sneezing and fever and contacted the doctor since he has copd, which had the same symptoms as covid-19.The consumer was also taking paxlovid.The consumer confirmed there was no patient harm due to the test results.
Additional Manufacturer Narrative
Corrected data: awareness date of this event is (b)(6) 2024.G3 - date received by mfg on report 1221359-2024-00653-00 should be 05oct2024.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 870976b 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 870976b and test base part number 195-430wjr/ lot 870976.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 870976b 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 possibly be 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: 20494072
• Report Number: 1221359-2024-00653
• Device Sequence Number: 3519343
• Product Code: QKP
• UDI-Device Identifier: 00811877011729
• UDI-Public: 01008118770117291726011210870976B
• 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,Followup
• Report Date (Section B): 11/29/2024

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: 01/12/2026
• Device Catalogue Number: 195-180
• Device Lot Number: 870976B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 11/25/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/30/2024; 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White