MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR ¿ AT-HOME COVID-19 TEST; NOT CLASSIFIED

Catalog Number 256094

Device Problem Unauthorized Access to Computer System (3025)

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(6).

Event Description

It was reported that while using the bd veritor ¿ at-home covid-19 test the customer encountered security issues and a malicious user attempted to obtain the customer's credentials.(b)(4).The following information was provided by the initial reporter: " it was reported that the customer¿s credit card information was compromised while using the test kit.".

Manufacturer Narrative

H6: investigation summary this statement is to summarize the investigation regarding a complaint that the user received a request to input his credit card after scanning the qr code on the side of the box.The device kit was identified as veritor at home (product number 256094), batch number unknown.Bd quality performs a systematic approach to investigate all complaints.This approach involves review for adverse trends and working in conjunction with the app developer where applicable.Based on the information available in this case, the reported complaint could not be confirmed and the root cause was not determined.As per product instructions, the user must first download the scanwell® health app, then sign up within the app if they are a first-time user, or log back in if they already have an account.After these steps, the app provides step-by-step video instructions to perform testing.At no point does it request credit card information.Accordingly it is unclear exactly what occurred in this case, but it does not appear to involved the scanwell® health app.This problem has been assessed as having no impact on the safety or efficacy of the product.No new hazards, risks, or specific trends were identified during this evaluation.H3 other text : see h10.

Event Description

It was reported that while using the bd veritor ¿ at-home covid-19 test the customer encountered security issues and a malicious user attempted to obtain the customer's credentials.(b)(4).The following information was provided by the initial reporter: " it was reported that the customer¿s credit card information was compromised while using the test kit.".

• Brand Name: BD VERITOR ¿ AT-HOME COVID-19 TEST
• Type of Device: NOT CLASSIFIED
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13182020
• MDR Text Key: 288499651
• Report Number: 1119779-2021-02099
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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