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 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

D4 (lot number, expiration number): both of the below listed lots were involved within this event, however, it's not evident which lot has attributed to the false result.Lot: 218339, expiration date: 27may2024.Lot: 218611, expiration date: 07jul2024.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 that her daughter had conflicting results with the binaxnow covid-19 self-test between two (2) tests performed on (b)(6) 2023 with different lot numbers.The consumer reported a positive result with the binaxnow covid-19 self-test performed on (b)(6) 2023 on a nasal sample using the provided kit swab.An additional test was performed later the same day ((b)(6) 2023) that generated a negative result utilizing the same testing type with a different lot number.Confirmation testing was not performed.The consumer stated that her daughter was symptomatic with "covid-like symptoms" but did not provide any further clarification.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

D4 (lot number, expiration number): both of the below listed lots were involved within this event, however, it's not evident which lot has attributed to the false result.Lot: 218339, expiration date: 27may2024 lot: 218611, expiration date: 07jul2024 testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 218339 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 218339 and device part number 195-430h / lot 214456.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 218339 showed that the complaint rate is (b)(4).Additionally, a review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 218339 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 possibly be related to the specific patient sample.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 218611 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 218611 and device part number 195-430wl / lot 216202.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 218611 showed that the complaint rate is 0.000352%.Additionally, a review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 218611 showed that the complaint rate is 0.00106%.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue however, it could possibly be related to the specific patient sample.Single use, device discarded.

Event Description

The consumer reported that her daughter had conflicting results with the binaxnow covid-19 self-test between two (2) tests performed on (b)(6) 2023 with different lot numbers.The consumer reported a positive result with the binaxnow covid-19 self-test performed on (b)(6) 2023 on a nasal sample using the provided kit swab.An additional test was performed later the same day (02may2023) that generated a negative result utilizing the same testing type with a different lot number.Confirmation testing was not performed.The consumer stated that her daughter was symptomatic with "covid-like symptoms" but did not provide any further clarification.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: 16911885
• MDR Text Key: 315278433
• Report Number: 1221359-2023-01109
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2023
• 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: 8 YR
• Patient Sex: Female
• Patient Weight: 36 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White