MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-160

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Fda udi ¿ (b)(4).B3: the date indicated 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.

Event Description

The consumer reported two false negative results with the binaxnow covid-19 antigen self-test performed on unknown dates.This manufacturer's report addresses test one (1) of two (2).Confirmation testing was not performed.Consumer performed two additional binaxnow covid-19 antigen self-tests on unknown dates and generated positive results.The consumer stated they are not well and is sick with covid.The consumer stated they had covid-19 but did not clarify the source of the diagnosis.Although requested, no additional patient information, including treatment and outcome, was provided.

Event Description

The consumer reported two false negative results with the binaxnow covid-19 antigen self-test performed on unknown dates.This manufacturer's report addresses test one (1) of two (2).Confirmation testing was not performed.Consumer performed two additional binaxnow covid-19 antigen self-tests on unknown dates and generated positive results.The consumer stated they are not well and is sick with covid.The consumer stated they had covid-19 but did not clarify the source of the diagnosis.Although requested, no additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Fda udi ¿ (b)(4).B3: the date indicated is an approximation as the exact event date was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 203265 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 195-160/ lot 203265 and test base part number 195-430h/ lot 198877.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 203265 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 patient sample.

• 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 Key: 18895256
• MDR Text Key: 337573281
• Report Number: 1221359-2024-00266
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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 Expiration Date: 02/19/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 203265
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/25/2024
• 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 Number: 1
• Patient Sex: Female