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 Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2023

Event Type  Death  

Manufacturer Narrative

B2: the date provided is an approximation as the exact date of death was not provided.B3: the date provided is an approximation as the exact date of event was not provided.The investigation of the consumer's complaint included a complaint trend analysis.There was no lot number information provided at the time the incident occurred to support further investigation activities.Based on the information available, a binaxnow covid-19 ag self test product deficiency was not identified.H3 other text : single use; device discarded.

Event Description

The consumer reported that an individual (relationship to reporter unknown) tested negative with the binaxnow covid-19 antigen self-test kit on an unknown date.The consumer indicated that the individual passed away the following day due to meningitis.The consumer inferred that the negative covid test may have contributed to the individual's death because "her mother was too worried about covid and not anything else".There was no additional covid testing performed and no inconsistency between the covid negative result and the cause of death.While there was no indication that the negative binaxnow covid-19 antigen self-test result was inaccurate, there is a possibility the binaxnow covid-19 antigen self-test result may have contributed to the individual's mother decision not to seek further testing or diagnosis of the individual's health condition.No additional information, including treatment, 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: 18237639
• MDR Text Key: 329373410
• Report Number: 1221359-2023-01690
• 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
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2023
• 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 Outcome(s): Death