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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 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device lot #: 0234987 was reported, however, this is not a lot# manufactured for this product #.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 testing for sars cov-2 a false positive result was obtained.A repeat test was performed using a pcr test method and the result was negative.There was no indication that results were reported out or any report of patient impact.No additional information was provided.(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 a pcr test method and the result was negative.There was no indication that results were reported out or any report of patient impact.No additional information was provided.Eua (b)(4).
 
Manufacturer Narrative
H.6.Investigation: 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 unknown.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 could not be performed as no batch number, or an incorrect batch number was provided.The complaint was unable to be confirmed.Quality will continue to closely monitor for trends.
 
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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 Key11091801
MDR Text Key225557860
Report Number1119779-2020-01287
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 09/22/2021
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 Number256082
Device Lot Number0234987
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received09/22/2021
Supplement Dates FDA Received10/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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