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 01/01/2024

Event Type  malfunction  

Event Description

The consumer reported two (2) false negative results with the binaxnow covid-19 antigen self test performed on different dates.This mfr.Report addresses test two (2) of two (2).Additional testing was performed (at the urgent care) on the (b)(6) 2024 with an unknown test (platform - unknown) which generated a positive result.Additional testing was performed (at the urgent care) on the (b)(6) 2024 with ihealth rapid test which generated a positive result.Repeat testing was performed several times over a week which generated a negative result.The consumer stated the patient did not get proper diagnosis due to false results.The consumer stated the patient was symptomatic.No additional patient information, including treatment and outcome, was provided.The consumer also reported the false negative results via medwatch (mw5150033 and mw5150034).

Manufacturer Narrative

The customer reported two affected lot numbers 225711 and 225201, since we are not certain of which test was performed on which date see below for lot information.Information for lot number: 225711.Expiration date: 23aug2024.Udi: (b)(4).Information for lot number: 225201.Expiration date: 29jul2024.Udi: (b)(4).The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single use device: device discarded.

Manufacturer Narrative

D4 udi: (b)(4).Date of event provided in section b3 is an approximation, was not provided by consumer.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 225201 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 225201, test base part number 195-430h / lot 220864.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 225201 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 have possibly been related to the specific patient sample.H3 other text : single use device: device discarded.

Event Description

The consumer reported false negative results with the binaxnow covid-19 antigen sefl-test performed on different dates.This mfr.Report is two (2) of three (3).The customer reported an unknown number of false negative results with the binaxnow covid-19 antigen self-test performed several times over a week.Additional testing was performed twice on (b)(6) 2024: once at an urgent care with an unknown test and the second with ihealth rapid test.Both methods generated a positive result.The consumer stated the patient was symptomatic and did not get proper diagnosis due to false results.No additional patient information, including treatment and outcome, was provided.The consumer reported the false negative results via medwatch (mw5150033 and mw5150034).

Manufacturer Narrative

D4 udi: (b)(4).Date of event provided in section b3 is an approximation, was not provided by consumer.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single use device: device discarded.

Event Description

The consumer reported false negative results with the binaxnow covid-19 antigen sefl-test performed on different dates.This mfr.Report is two (2) of three (3).The customer reported an unknown number of false negative results with the binaxnow covid-19 antigen self-test performed several times over a week.Additional testing was performed twice on (b)(6) 2024: once at an urgent care with an unknown test and the second with ihealth rapid test.Both methods generated a positive result.The consumer stated the patient was symptomatic and did not get proper diagnosis due to false results.No additional patient information, including treatment and outcome, was provided.The consumer reported the false negative results via medwatch (mw5150033 and mw5150034).

• 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: 18637665
• MDR Text Key: 334494296
• Report Number: 1221359-2024-00140
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2024

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: 225201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/04/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 03/07/2024
• Supplement Dates FDA Received: 02/08/2024; 03/12/2024
• 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