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 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use, device discarded.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on 07mar2023 on a nasal sample.Initial testing was performed using the binaxnow covid-19 antigen self-test kit.Before 15 minutes, the consumer reopened the test card and rotated the swab an additional time before closing the test card.After 15 minutes, the binaxnow covid-19 antigen self-test kit generated a positive result.Repeat testing was performed on the same day generating a negative result.Confirmation testing was not performed.The consumer confirmed there was no patient harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in the patient's treatment.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on (b)(6) 2023 on a nasal sample.Initial testing was performed using the binaxnow covid-19 antigen self-test kit.Before 15 minutes, the consumer reopened the test card and rotated the swab an additional time before closing the test card.After 15 minutes, the binaxnow covid-19 antigen self-test kit generated a positive result.Repeat testing was performed on the same day generating a negative result.Confirmation testing was not performed.The consumer confirmed there was no patient harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 211656 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: 211656, test base part number 195-430h/ lot: 208044.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 211656 showed that the complaint rate is (b)(4) % respectively.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could have possibly been related to issues including the customer opened test card during wait time.H3 other text : single use, device discarded.

• 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: 16541542
• MDR Text Key: 311372919
• Report Number: 1221359-2023-00497
• 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: 05/16/2023

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 Expiration Date: 05/10/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 211656
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/16/2023
• 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 Age: 4 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White