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

Catalog Number 256094

Device Problem False Negative Result (1225)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

It was reported bd veritor ¿ at-home covid-19 test false negatives after testing at home.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes; hazard, injury or erroneous results details three tests taken by two family members came back negative when they were fully symptomatic.Tested at urgent care same day and both were positive.Don¿t waste your money.

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation regarding a complaint that involved a veritor at home (product number 256094), batch number unknown.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of adverse trends, manufacturing batch history records, testing of retention samples, and testing of customer returned samples and working in conjunction with the app developer where applicable if applicable.An investigation could not be performed because a batch number was not provided.The complaint was unable to be confirmed.The root cause could not be identified.A trend analysis for the reported issues "false negative" was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.H3 other text : see h.10.

Event Description

It was reported bd veritor ¿ at-home covid-19 test false negatives after testing at home.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details three tests taken by two family members came back negative when they were fully symptomatic.Tested at urgent care same day and both were positive.Don¿t waste your money.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.It has been confirmed that the complaint received via social media was not for a bd product, and therefore, is not considered to be a reportable malfunction.

Event Description

It was reported bd veritor ¿ at-home covid-19 test false negatives after testing at home.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes hazard, injury or erroneous results details three tests taken by two family members came back negative when they were fully symptomatic.Tested at urgent care same day and both were positive.Don¿t waste your money.

• 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: 15982973
• MDR Text Key: 306900682
• Report Number: 1119779-2022-01483
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

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: Other
• Device Catalogue Number: 256094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/11/2023; 01/30/2023
• Supplement Dates FDA Received: 01/17/2023; 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1