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 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.Device discarded, single use.

Event Description

The consumer reported a false negative result with binaxnow covid-19 ag self-test on (b)(6) 2022, on nasal swab.The consumer received a positive result with unknown brand on (b)(6) 2022, and a negative result with binaxnow covid-19 ag self-test on (b)(6) 2022.The consumer stated that she had a fever on (b)(6) 2022 and took vaccine last week.No additional patient information, including treatment and outcome, was provided.

Event Description

The consumer reported a false negative result with binaxnow covid-19 ag self-test on (b)(6) 2022, on nasal swab.The consumer received a positive result with unknown brand on (b)(6) 2022, and a negative result with binaxnow covid-19 ag self-test on (b)(6) 2022.The consumer stated that she had a fever on (b)(6) 2022 and took vaccine last week.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 211256 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 211256, test base part number 195-430h / lot 207584.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 211256 showed that the complaint rate is (b)(4).A product deficiency has not been identified.Based on the above summary, the investigation is deemed closed.The product will continue to be monitored and tracked.H3 other text: device discarded, single use.

• 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: 15758903
• MDR Text Key: 307578330
• Report Number: 1221359-2022-10078
• 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: 01/26/2023

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
• Device Lot Number: 211256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/26/2023
• 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 Sex: Female