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 Use of Device Problem (1670)

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

Event Date 01/08/2023

Event Type  Injury  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use; device discarded.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on (b)(6) 2023.Per the consumer, she added six drops of reagent to the test card then inserted the swab into the test card before taking her nasal sample.Realizing her error, she removed the swab from the test card (that was reportedly "dipped in reagent"), swabbed both nostrils, and re-inserted the swab into the test card.The consumer denied any burning within the nostril and reportedly took no remedial action.Additionally, she confirmed that she is "feeling good and doesn't have any discomfort".There was no reported patient impact.Additionally, the consumer reported that her test kit only contained a spanish language package insert.

Event Description

The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on 08jan2023.Per the consumer, she added six drops of reagent to the test card then inserted the swab into the test card before taking her nasal sample.Realizing her error, she removed the swab from the test card (that was reportedly "dipped in reagent"), swabbed both nostrils, and re-inserted the swab into the test card.The consumer denied any burning within the nostril and reportedly took no remedial action.Additionally, she confirmed that she is "feeling good and doesn't have any discomfort".There was no reported patient impact.Additionally, the consumer reported that her test kit only contained a spanish language package insert.

Manufacturer Narrative

A product deficiency was not reported or found.The customer refused sds and stated they are not facing any discomfort.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.H3 other text : single use; device discarded.

• 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: 16151539
• MDR Text Key: 307261589
• Report Number: 1221359-2023-00066
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 218644
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2023
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/17/2023
• 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 Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White