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

Catalog Number 195-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Contact Dermatitis (4546)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the nurse performing the binaxnow covid-19 ag card first applied drops to top well and then inserted swab into bottom well and pushed up into reagent, prior to removing swab from test card and then swabbing the patient's nasal nares.The msds was sent to the customer and the patients nasal nares were then flushed with saline.The customer states the patient experienced inflammation in nasal nares and emotional distress.The customer states there was serious injury related to the event and no medical treatment was required.

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 AG CARD
• 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: 12973097
• MDR Text Key: 283685661
• Report Number: 1221359-2021-03710
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Device Lot Number: 167113
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female