MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 ANTIGEN SELF TEST; 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 Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The customer reported a false positive result with the id now covid-19 assay performed.Confirmation testing was performed with pcr generated negative results.Repeat testing was then performed generating negative results.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

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 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: kindra sudduth ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13123216
• MDR Text Key: 284652057
• Report Number: 1221359-2021-04002
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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 Catalogue Number: 195-160
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2022
• 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