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 Non Reproducible Results (4029)

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

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The consumer reported a conflicting result with binaxnow covid-19 ag self-test on 04apr2023 on nasal swab.The consumer received a negative result and a positive result with binaxnow covid-19 ag self test on 04apr2023.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 214300 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 214300 and device part number 195-430wl/ lot 212659.The lot met the required release specifications.A review of the complaints reported as false positive and/or false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 214300 showed that the complaint rate is (b)(6).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.(b)(4) device discarded, single use.

Event Description

The consumer reported a conflicting result with binaxnow covid-19 ag self-test on (b)(6) 2023 on nasal swab.The consumer received a negative result and a positive result with binaxnow covid-19 ag self test on (b)(6) 2023.No additional patient information, including treatment and outcome, was provided.

• 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: 16707653
• MDR Text Key: 312965849
• Report Number: 1221359-2023-00605
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 214300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2023
• 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