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

Catalog Number 195160

Device Problem Use of Device Problem (1670)

Patient Problem Epistaxis (4458)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The consumer reported a lot of blood was notice on the swab with the binaxnow¿ covid-19 antigen self test performed on (b)(6) 2021.The consumer performed test this morning and reported a lot of blood eminating from nostril and on swab.The consumer reported the swab as being dark red.He reported that the blue control line had changed to a dark red when he read results after 15 minutes.The consumer reported no other lines on test card.The consumer refused further assistance and reported he was going to see his doctor in the afternoon.The consumer reported a pre-existing health condition and a low plantlet count and was unsure if he should repeat the test.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

A product deficiency was not identified and no further action is required.Based on the above summary, the investigation is deemed complete.The product will continue to be monitored and tracked.

• Brand Name: BINAX NOW 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: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12834675
• MDR Text Key: 280932736
• Report Number: 1221359-2021-03519
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

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: Health Professional
• Device Catalogue Number: 195160
• Device Lot Number: 146864
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male