MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256089

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 03/12/2021

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.

Event Description

It was reported while testing for sars cov-2 an alleged false negative result was obtained.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.A repeat test was performed using pcr and the result was negative.There was no indication that results were reported out and there was no report of patient impact.Eua#: (b)(4).The following information was provided by the initial reporter: " up on directly talking to the customer informed that it is actually a false negative that they obtained through bd veritor plus analyzer.The customer tested eight family members and all came negative with the bd veritor sars cov 2 assay.But with the pcr one person who is asymptomatic tested positive, they did rapid test again with the veritor which came came out negative.The customer is now suspecting the pcr to be false positive, but in order to confirm it they may have to spent more for additional testings and itherefore is hesitant to do so.Customer had to perform pcr as well as rapid test to others due to this incident.Wanted to have an explanation for if false negative.".

Manufacturer Narrative

Eua#: (b)(4).Investigation summary: bd has received several customer complaints for false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd veritor¿ system.Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.Due to unknown lot# a dhr could not be performed.The investigation did not find a root cause for the false positive results that were observed.It is recommended that each customer review their workflow carefully to ensure that the package insert is being followed as written.The root cause is under investigation and will be documented in our quality system.Bd cannot confirm the complaint based on the investigation that was performed.A corrective and preventive action (capa#(b)(4)) is already initiated to investigate the root cause and some mitigation actions are already being addressed.

Event Description

It was reported while testing for sars cov-2 an alleged false negative result was obtained.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.A repeat test was performed using pcr and the result was negative.There was no indication that results were reported out and there was no report of patient impact.Eua#: (b)(4).The following information was provided by the initial reporter: " up on directly talking to the customer informed that it is actually a false negative that they obtained through bd veritor plus analyzer.The customer tested eight family members and all came negative with the bd veritor sars cov 2 assay.But with the pcr one person who is asymptomatic tested positive, they did rapid test again with the veritor which came out negative.The customer is now suspecting the pcr to be false positive, but in order to confirm it they may have to spent more for additional testings and therefore is hesitant to do so.Customer had to perform pcr as well as rapid test to others due to this incident.Wanted to have an explanation for if false negative.".

Manufacturer Narrative

Investigation: this investigation is to summarize the complaints that alleges false negative or discrepant results when using kit bd veritor for rapid detection of sars-cov-2 ce (mn# 256089), batch number unknown.Bd quality performs a systematic approach to investigate false negative complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.The investigation could not be performed as no batch number was provided.The complaint was unable to be confirmed.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported while testing for sars cov-2 an alleged false negative result was obtained.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.A repeat test was performed using pcr and the result was negative.There was no indication that results were reported out and there was no report of patient impact.Eua#: (b)(4).The following information was provided by the initial reporter: "up on directly talking to the customer informed that it is actually a false negative that they obtained through bd veritor plus analyzer.The customer tested eight family members and all came negative with the bd veritor sars cov 2 assay.But with the pcr one person who is asymptomatic tested positive, they did rapid test again with the veritor which came out negative.The customer is now suspecting the pcr to be false positive, but in order to confirm it they may have to spent more for additional testings and therefore is hesitant to do so.Customer had to perform pcr as well as rapid test to others due to this incident.Wanted to have an explanation for if false negative.".

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11634511
• MDR Text Key: 274347406
• Report Number: 1119779-2021-00623
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2021

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: 256089
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 07/02/2021; 09/10/2021
• Supplement Dates FDA Received: 07/12/2021; 09/22/2021
• 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