MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-000

Device Problems False Negative Result (1225); Unable to Obtain Readings (1516)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The customer reported a false negative result with the binaxnow covid-19 ag card assay performed on (b)(6) 2021 on a direct tested nasal kitted swab.The nasal swab was used [to swab both nostrils per the product insert instructions.Repeat testing was performed with a new binaxnow covid-19 ag card assaycard with a new sample.The testing results were positive.The customer stated the patient was symptomatic for 3 to 7 days prior to test.No patient treatment was provided.The customer confirmed there was no patient harm due to the test results.Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.Negative results do not rule out sars-cov-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with covid-19.Due to the risk of a false negative result potentially leading to no or delayed treatment, this event shall be considered reportable.

Manufacturer Narrative

This supplemental report is being submitted to report the investigation conclusion and additional information.Additional information: expiration and manufacturer date.Investigation: testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 130112 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 130112, test base part number 195-430h / lot 128715a.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 130112 showed that the complaint rate is (b)(4).Abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issue; however based on the information provided by the customer and the images provided for review it appeared to be related to manufacturing execution.

Manufacturer Narrative

After additional investigation of the event, it was determined the customer did not experience a false negative result.The investigation confirmed the test strip of the binaxnow covid-19 ag card was placed at a lower position than specified.The customer suspected this misalignment to be cause for a false negative.Based on investigator review of the pictures provided by the customer, the result is considered to be invalid by definition.The investigator observed the test results were invalid as described in the package insert, as only the sample line appeared in the control window area.Per the product insert, "invalid: if no lines are seen, if just the sample line is seen, or the blue control line remains blue, the assay is invalid.Invalid tests should be repeated.Result interpretation: note: in an untested binaxnow covid-19 ag card there will be a blue line present at the control line position.In a valid, tested device, the blue line washes away and a pink/purple line appears, confirming that the sample has flowed through the test strip and the reagents are working.If the blue line is not present at the control line position prior to running the test, do not use and discard the test card".It was determined the low position of the control lines in these photographs indicate a manufacturing defect.Testing was performed at (b)(4).On retained kit lot 130112 with internal positive quality control samples and negative quality control swabs.All testing was valid and performed as expected with no observations of false results or line placement device defects.The manufacturing records and quality control release testing was reviewed for kit part number 195-000 / lot 130112 and device part number 195-430h / lot 128715a.Quality control release testing met specifications and there were no false negative results or misplaced test strips observed.As a false result did not occur, this event is no longer considered to be reportable.Based on the product risk assessment of invalid results, the possibility of death or serious injury is remote.

• Brand Name: BINAXNOW COVID-19 AG CARD
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough,; ME 04074
• MDR Report Key: 11645992
• MDR Text Key: 262614449
• Report Number: 1221359-2021-00930
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721040910130112
• Combination Product (y/n): N
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: 195-000
• Device Lot Number: 130112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1