MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-000

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

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 customer reported three (3) false positive results with the binax now covid-19 ag card for multiple patients performed on various days.This mfr.Report addresses report one (1) of three (3).The customer reported an unknown number of confirmed false positive results with the binax now covid-19 ag card performed on (b)(6) 2023 using kit nasal swab.Confirmation testing via molecular (platform - solona by quidel) was performed on (b)(6) 2023 which generated a negative result using utm swab.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

D4: udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 227446y 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 195-000/lot 227446y, test base part number 195-430h/lot 223594.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 227446y 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 possibly be related to issues including the self-test user performance, storage conditions of the test cards, interpretation of the result, or the specific patient sample.H3 other text: single-use, device discarded.

Event Description

The customer reported three (3) false positive results with the binax now covid-19 ag card for multiple patients performed on various days.This mfr.Report addresses report one (1) of three (3).The customer reported a false positive result with the binax now covid-19 ag card performed on (b)(6) 2023 using kit nasal swab.Confirmation testing via molecular (platform - solona by quidel) was performed (b)(6) 2023 which generated a negative result using utm swab.No additional patient information, including treatment and outcome, was provided.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• 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: 18351136
• MDR Text Key: 331065602
• Report Number: 1221359-2023-01765
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 10811877011290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Device Lot Number: 227446Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• 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