MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 4CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-180

Device Problem False Positive Result (1227)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

The consumer reported a false positive result with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024.Repeat testing was not performed.Confirmation testing was not performed.Consumer performed an antigen self-test with a different brand on (b)(6) 2024 and generated a negative result.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Fda udi - (b)(4).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

Fda udi - (b)(6) testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 228064 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 195-180/ lot 228064 and test base part number 195-430h/ lot 224151.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 228064 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 possibly be related to issues including the self-test user performance or the specific patient sample.H3 other text : single use; device discarded.

Event Description

The consumer reported a false positive result with the binaxnow covid-19 antigen self-test performed on (b)(6)2024.Repeat testing was not performed.Confirmation testing was not performed.Consumer performed an antigen self-test with a different brand on (b)(6)2024 and generated a negative result.No additional patient information, including treatment and outcome, was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 4CT
• 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: 18683370
• MDR Text Key: 335114522
• Report Number: 1221359-2024-00164
• Device Sequence Number: 1
• Product Code: QKP
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-180
• Device Lot Number: 228064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• 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 Sex: Female