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 Positive Result (1227)

Patient Problems Diarrhea (1811); Fever (1858); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The consumer reported two (2) false positive results with the binaxnow covid-19 ag self-test performed on her on (b)(6) 2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false positive result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022.Confirmation testing was performed at a doctor facility and generated a negative result (platform unknown).The consumer was symptomatic to covid-19 (diarrhea, fever and respiratory symptoms), furthermore consumer stated that even her doctor was confused about the confirmatory test negative result.No additional patient information, including treatment and outcome, was provided.

Event Description

The consumer reported two (2) false positive results with the binaxnow covid-19 ag self-test performed on her (b)(6) 2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false positive result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022.Confirmation testing was performed at a doctor facility and generated a negative result (platform unknown).The consumer was symptomatic to covid-19 (diarrhea, fever and respiratory symptoms), furthermore consumer stated that even her doctor was confused about the confirmatory test negative result no additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

This supplement report is submitting to retract/correct the initial report that was submitted for false positive, further case review/additional information confirmed that there was no allegation of false positive results against our product.H6 updated, inadvertently omitted from initial report.H3 other text : device discarded, single use device.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 211622 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 211622, test base part number 195-430h / lot 207659.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 211622 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However, a possible assignable root cause is sample interference or cross contamination.H3 corrected h3 other text : device discarded, single use device.

Event Description

The consumer reported two (2) false positive results with the binaxnow covid-19 ag self-test performed on her (b)(6)2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false positive result with the binaxnow covid-19 ag self-test performed on (b)(6)2022.Confirmation testing was performed at a doctor facility and generated a negative result (platform unknown).The consumer was symptomatic to covid-19 (diarrhea, fever and respiratory symptoms), furthermore consumer stated that even her doctor was confused about the confirmatory test negative result 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: 15712506
• MDR Text Key: 307574922
• Report Number: 1221359-2022-10048
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 211622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White