MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-160

Device Problem Non Reproducible Results (4029)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event provided in section b3 is an approximation, was not provided by customer.D4: the consumer reported two lot numbers 183181 and 184270 for tests performed.Since we are not certain of which test provided the correct result see below for lot information.Information for lot no.183181.Expiration date: 23nov2023.Information for lot number 184270.Expiration date: 25nov2023.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use device: device discarded.

Event Description

The customer reported on behalf of her mother a case of conflicting results with the binaxnow covid-19 antigen self test performed on unknown date.The consumer reported that positive and negative results were generated after testing with the binaxnow on an unknown date.Confirmation testing was not performed.The customer confirmed there was no patient harm due to the test results.No additional information was provided.

Manufacturer Narrative

Date of event provided in section b3 is an approximation, was not provided by customer.D4: the consumer reported two lot numbers 183181 and 184270 for tests performed.Since we are not certain of which test provided the correct result see below for lot information.Information for lot no.183181.Expiration date: 23nov2023.Information for lot number 184270.Expiration date: 25nov2023.Investigation results: testing was performed in triplicate at abbott diagnostics scarborough, inc.On retained kit lot 183181 and 184270 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 183181 / lot 184270 and device part number 195-430wl / lot 181167 and 195-430h / lot 181392.The lot met the required release specifications.A review of the complaints reported as false negative and false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 183181 showed that the complaint rate is (b)(4) respectively.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 184270 showed that the complaint rate is (b)(4) respectively.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to the specific patient sample.B3 - date of event.H3 other text : single use device: device discarded.

Event Description

The customer reported on behalf of her mother a case of conflicting results with the binaxnow covid-19 antigen self test performed on unknown date.The consumer reported that positive and negative results were generated after testing with the binaxnow on an unknown date.Confirmation testing was not performed.The customer confirmed there was no patient harm due to the test results.No additional information was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 2CT
• 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: 17058331
• MDR Text Key: 316678657
• Report Number: 1221359-2023-01193
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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