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 03/02/2024

Event Type  malfunction  

Event Description

The consumer reported two (2) false negative results with the binaxnow covid-19 antigen self test for two tests performed on (b)(6) 2024 and (b)(6) 2024.This mfr.Report addresses test two (2) of two (2).Additional testing was performed (at a doctor office) on the (b)(6) 2024 with an unknown brand covid-19 test (platform - unknown) which generated a positive result.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

D4 udi: (b)(4).The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single-use, device discarded.

Event Description

The consumer reported two (2) false negative results with the binaxnow covid-19 antigen self test for two tests performed on (b)(6) 2024 and (b)(6) 2024.This mfr.Report addresses test two (2) of two (2).Additional testing was performed (at a doctor office) on the (b)(6) 2024 with an unknown brand covid-19 test (platform - unknown) which generated a positive result.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

D4 udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 227660 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 227660, test base part number 195-430h/ lot 223674.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 227660 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 specific 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: 18929582
• MDR Text Key: 337993300
• Report Number: 1221359-2024-00276
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 227660
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2023
• 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