MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-000

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

The customer reported 56 false negatives results with the binaxnow¿ covid-19 antigen card performed between (b)(6) 2021 and (b)(6) 2021.This mfr.Report addresses patient 46 of 56.The customer reported (1) false negative result with the binaxnow¿ covid-19 antigen card performed on (b)(6) 2021, using oropharyngeal swab sample.Pcr confirmation testing on oropharyngeal samples with amplitude generated positive results (ct values = 31.5).The customer reported that the patient was symptomatic.No additional patient information, including treatment and outcome, was provided.In addition, the customer has reported that they have sequestered 28587 individual kits of the binaxnow¿ covid-19 antigen card test for the mentioned lot number due to the false negatives the customer has received with the product.Since the customer confirmed the previously reported 7 false negative results are included in the 56 results mentioned an additional 49 reports will be submitted to address this complaint.

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.Please also reference mfr.Report #s 1221359-2021-03435, 1221359-2021-02489, 1221359-2021-03769 thru 1221359-2021- 03774 and 1221359-2021-03775 thru 1221359-2021-03822.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Please see updates: g3, g6, h2 and h6.The customer returned kits were tested with the following: 70 lod and 4 negative control (blank swab).4 customer kits were received and split as detailed below kit 1: tested 18 lod and 1 negative control kit 2: tested 18 lod and 1 negative control kit 3: tested 17 lod and 1 negative control kit 4: tested 17 lod and 1 negative control all testing was valid and performed as expected with no false negative or invalid results observed.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 131522 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 191-000 / lot 131522 and test base part number 190-430 / lot 131522.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 131522 showed that the complaint rate is (b)(4).In conclusion, the manufacturing batch record review (brr) revealed that the product met acceptance criteria for release, and review of complaints against the kit lot for the reported issue indicates that the product is performing according to the statements contained in the package insert and a product deficiency has not been identified.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 samples.

Manufacturer Narrative

This report is being submitted to correct the following fields of the intial report.Please see corrected fields: d1, d2, d3, d4, g3, g4 and h8.

• Brand Name: BINAXNOW COVID-19 AG CARD
• 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 ; 2077305717
• MDR Report Key: 13108598
• MDR Text Key: 284188708
• Report Number: 1221359-2021-03813
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721042610131522
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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: 131522
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1