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 09/19/2023

Event Type  malfunction  

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on (b)(6) 2023.On (b)(6) 2023,.The first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Additional testing was not performed.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.

Manufacturer Narrative

The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend / unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : single use; device discarded.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on (b)(6) 2023.On (b)(6) 2023, the first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Additional 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: 17858253
• MDR Text Key: 324908077
• Report Number: 1221359-2023-01474
• 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: 10/20/2023

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 Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 10/20/2023
• 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