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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR; CORONAVIRUS ANTIGEN DETECTION SYSTEM Back to Search Results
Catalog Number 256082
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
Eua # (b)(4).Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained, however, (b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported while testing for sars-cov-2 the customer tested herself using the positive control swab twice.Multiple attempts have been made to obtain additional information, the customer has not responded.Eua # (b)(4).The following information was provided by the initial reporter: customer tested herself with positive control swab and received a positive results then tested her self again with a regular swab and received a negative result, and then tested her self a third time using a positive control swab, which resulted as positive.Customer could not provide lot# or instrument sn.Customer is going to get tested with pcr.Customer does not allege a defect with bd reagents or analyzer.3 follow up attempts.No response from the customer.
 
Event Description
It was reported while testing for sars-cov-2 the customer tested herself using the positive control swab twice.Multiple attempts have been made to obtain additional information, the customer has not responded.Eua # (b)(4) the following information was provided by the initial reporter: customer tested herself with positive control swab and received a positive results then tested her self again with a regular swab and received a negative result, and then tested her self a third time using a positive control swab, which resulted as positive.Customer could not provide lot# or instrument sn.Customer is going to get tested with pcr.Customer does not allege a defect with bd reagents or analyzer.3 follow up attempts.No response from the customer.
 
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#1878253) is already initiated to investigate the root cause and some mitigation actions are already being addressed.
 
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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
MDR Report Key11634896
MDR Text Key244443293
Report Number1119779-2021-00625
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number256082
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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