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 12/06/2022

Event Type  malfunction  

Event Description

He customer reported unconfirmed false positive results with the binaxnow covid-19 antigen card performed on and after (b)(6) 2022 involving an unknown quantity of patients and one lot number 218991.The test was performed with the kit swab on nasal samples.Additional testing was performed using another binaxnow covid-19 antigen card performed on an unknown date with another lot number and generated a negative result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Manufacturer Narrative

Testing was performed in triplicate at abbott diagnostics scarborough, inc.On retained kit lot 218991 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 195-000/ lot 218991 and device part number 195-430h/ lot 215893.The lot met the required release specifications.The review of the complaints reported as false positive patient results (confirmed, unconfirmed and conflicting results) related to kit lot 218991 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 the specific patient sample.H3 other text : device discarded; single-use device.

Event Description

The customer reported unconfirmed false positive results with the binaxnow covid-19 antigen card performed on and after 06dec2022 involving an unknown quantity of patients and one lot number 218991.The test was performed with the kit swab on nasal samples.Additional testing was performed using another binaxnow covid-19 antigen card performed on an unknown date with another lot number and generated a negative result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Event Description

The customer reported unconfirmed false positive results with the binaxnow covid-19 antigen card performed on and after (b)(6) 2022 involving around 10 patients and one lot number 218991.The test was performed with the kit swab on nasal samples.This mfr.Report addresses result one (1) of ten (10).Additional testing was performed using another binaxnow covid-19 antigen card performed on an unknown date with another lot number and generated a negative result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

Additional information: b5: updated from unknown number of patients to about 10 patients.Date of event provided in section b3 is an approximation, was not provided by consumer.Testing was performed in triplicate at abbott diagnostics scarborough, inc.On retained kit lot 218991 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 195-000/ lot 218991 and device part number 195-430h/ lot 215893.The lot met the required release specifications.The review of the complaints reported as false positive patient results (confirmed, unconfirmed and conflicting results) related to kit lot 218991 showed that the complaint rate is 0.00854%.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to the specific patient sample.H10: report complaint rate updated from (b)(4)% to (b)(4)%.H3 other text : device discarded; single-use device.

• 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: 16070012
• MDR Text Key: 308539354
• Report Number: 1221359-2022-10421
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Catalogue Number: 195-000
• Device Lot Number: 218991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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