MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem False Positive Result (1227)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is still in progress.Once the investigation is completed, a supplemental report will be provided.

Event Description

The consumer reported a false positive result using the binaxnow¿ covid-19 antigen self test otc, 2 test pack on (b)(6) 2021.The consumer reported that she generated a negative result using an unspecified rapid covid-19 test.Technical services (ts) advised that the consumer obtain a pcr confirmation test.The consumer confirmed that she had taken a pcr test and is awaiting the results.Ts was unsuccessful in obtaining a response to follow ups regarding the results of the pcr test taken by the consumer.The consumer did not indicate to ts if symptoms were present.As of this report, no further information is available.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Additional information: d4: expiration date investigation report: testing was performed in triplicate at abbott diagnostics scarborough, inc.On retained kit lot 160048 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 160048 and device part number 195-430wl/lot 152901.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 160048 showed that the complaint rate is 0.0003%.In conclusion, the retention testing yielded expected results when testing internal qc samples, 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 issues including the self-test user performance, interpretation of the result, or the specific patient sample.

• Brand Name: BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• 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: 13119330
• MDR Text Key: 284186101
• Report Number: 1221359-2021-03912
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722032010160048
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2022
• Device Catalogue Number: 195-160
• Device Lot Number: 160048
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female