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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 Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated results were reported out, but there was no report of patient impact.Eua#: (b)(4).
 
Manufacturer Narrative
H6: investigation summary this statement is to summarize the investigation results regarding the complaint that alleges false positive results when using kit rapid detection of sars-cov-2 veritor (material # 256082 ), batch number 0237227.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation was performed on the batch number provided.The reported issue was unable to be confirmed.However, there is a trend against false positive results.Bd has initiated capa (corrective and preventive action) # 1878253 to further investigate.The root cause could not be identified.Bd quality will continue to closely monitor for trends.
 
Event Description
It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated results were reported out, but there was no report of patient impact.Eua #: (b)(4).
 
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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 Key11023322
MDR Text Key224398525
Report Number1119779-2020-01236
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 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/22/2020
Device Catalogue Number256082
Device Lot Number0237227
Was Device Available for Evaluation? No
Date Manufacturer Received10/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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