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 False Positive Result (1227)

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

Event Date 04/13/2024

Event Type  malfunction  

Manufacturer Narrative

B3: the date provided is an approximation as the exact event date was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The consumer reported four (4) false positive results with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024.This mfr.Report addresses test one (1) of four (4).The customer reported a false positive result with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024 on an unknown sample type.Additional testing was performed at the doctor¿s office on an unknown date via an unknown method which generated a negative result.No additional information, including treatment and outcome, was provided.

Event Description

The consumer reported four (4) false positive results with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024.This mfr.Report addresses test one (1) of four (4).The customer reported a false positive result with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024 on an unknown sample type.Additional testing was performed at the doctor¿s office on an unknown date via an unknown method which generated a negative result.No additional information, including treatment and outcome, was provided.

Manufacturer Narrative

B3: the date provided is an approximation as the exact event date was not provided.The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints¿ trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

• 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: 19150015
• MDR Text Key: 340804804
• Report Number: 1221359-2024-00363
• Device Sequence Number: 1
• Product Code: QKP
• 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: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/21/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/16/2024
• 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