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 03/25/2023

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 196077 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 kit part number 195-160/ lot 196077 and device part number 195-430h/ lot 191574.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 196077 showed that the complaint rate is 0.000331%.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 196077 showed that the complaint rate is 0.000331%.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue, however, it could possibly be related to the specific patient sample.

Event Description

The consumer reported two (2) conflicting results with the binaxnow covid-19 antigen self-test for multiple tests performed on (b)(6) 2023 on a nasal sample.This mfr.Report addresses test two (2) of two (2).The consumer reported that the test generated a positive result when read at the fifteen (15) minute mark, but that the sample line disappeared before the thirty (30) minute mark.Confirmation testing was not performed.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: 16683579
• MDR Text Key: 312869791
• Report Number: 1221359-2023-00577
• 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
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 196077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White