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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.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.(b)(4).
 
Event Description
It was reported while using a bd rapid detection of sars-cov-2 veritor assay a false negative result was obtained.A repeat test was performed using a pcr test method and the result was negative.The customer stated the patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no report of patient impact.(b)(4).
 
Event Description
It was reported while using a bd rapid detection of sars-cov-2 veritor assay a false negative result was obtained.A repeat test was performed using a pcr test method and the result was negative.The customer stated the patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no report of patient impact.Eua(b)(4).
 
Manufacturer Narrative
Investigation summary: this memo is to summarize the investigation results regarding the complaints that alleges false negative result when using kit bd veritor for rapid detection of sars-cov-2 (mn# 256082), batch number 0221748 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.An investigation and testing were performed on the batch number 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.H3 other text : see h10.
 
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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 Key10763809
MDR Text Key215343630
Report Number1119779-2020-00858
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/21/2021
Device Catalogue Number256082
Device Lot Number0221748
Was Device Available for Evaluation? No
Date Manufacturer Received10/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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