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 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

D4-lot:224390; d4-expiration:8/12/2024; d4-udi:(b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : 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 kitted swab.On (b)(6) 2023, the first test taken (lot number: unknown) generated a negative result, and the second test (lot number:224390), performed on the same day, generated a positive result.Repeat testing was performed on (b)(6) 2023 which generated a positive result.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.

Manufacturer Narrative

Second test lot information: d4-lot:224390 d4-expiration:8/12/2024 d4-udi:(b)(4).Investigation results: customer was unable to provide the lot number for the first test.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.Testing was performed in triplicate at abbott diagnostics scarborough, inc.On retained kit lot 224390 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 kit part number 195-160/ lot 224390 and device part number 195-430h/ lot 220619.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 224390 showed that the complaint rate is 0.(b)(4).A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 224390 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on 19oct2023 on a nasal kitted swab.On 19oct2023, the first test taken (lot number: unknown) generated a negative result, and the second test (lot number:224390), performed on the same day, generated a positive result.Repeat testing was performed on 20oct2023 which generated a positive result.The consumer confirmed there was no harm due to the test results.Additionally, the consumer 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 kitted swab.On (b)(6) 2023, the first test taken (lot number: unknown) generated a negative result, and the second test (lot number:224390), performed on the same day, generated a positive result.Repeat testing was performed on (b)(6) 2023 which generated a positive result.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.

Manufacturer Narrative

Second test lot information: d4-lot: 224390, d4-expiration: 8/12/2024, and d4-udi: (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.B5-corrected date of occurrence month from september to october.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: 18051825
• MDR Text Key: 327296220
• Report Number: 1221359-2023-01608
• 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,Followup
• Report Date: 11/21/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/10/2023; 11/17/2023
• Supplement Dates FDA Received: 11/16/2023; 11/21/2023
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White