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 Problems False Positive Result (1227); Poor Quality Image (1408)

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

Event Date 12/15/2022

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

Customer reported an unconfirmed false positive result using the binax now covid-19 ag self test performed on (b)(6) 2022.Customer also reported taking a negative test result on (b)(6) 2022 with an unknown test brand.Confirmation testing was not performed, and no symptoms were reported.No additional patient information, including treatment and outcome, was provided.The customer did not report any patient harm due to the results.Additionally, the customer did not report any delay or impact in treatment.

Event Description

Customer reported an unconfirmed false positive result using the binax now covid-19 ag self test performed on (b)(6) 2022.Customer also reported taking a negative test result on (b)(6) 2022 with an unknown test brand.Confirmation testing was not performed, and no symptoms were reported.No additional patient information, including treatment and outcome, was provided.The customer did not report any patient harm due to the results.Additionally, the customer did not report any delay or impact in treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 211897 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: 211897, test base part number 195-430h / lot: 207615.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 211897 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could have possibly been related to the specific patient sampled4: expiration date extended to 25apr2024.E1: na for phone number h6: medical device problem code changed to a090804 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: 16042967
• MDR Text Key: 308470493
• Report Number: 1221359-2022-10402
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 211897
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White