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 05/09/2023

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 (b)(6) 2023 on a nasal sample.On (b)(6) 2023, the first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Additional testing was not performed.The consumer confirmed there was no harm due to the test results and confirmed there was no delay or impact in 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.On (b)(6) 2023, the first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Additional testing was not performed.The customer was reportedly asymptomatic but tested due to potential exposure and a spouse exhibiting symptoms.The consumer confirmed there was no harm due to the test results and confirmed there was no delay or impact in treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 217759 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: 217759, test base part number 195-430h/ lot: 213684.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 217759 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 the specific patient sample.B5 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: 16963184
• MDR Text Key: 315657792
• Report Number: 1221359-2023-01144
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 217759
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White