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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD RAPID DETECTION OF SARS-COV-2 VERITOR; CORONAVIRUS ANTIGEN DETECTION SYSTEM
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 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 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Eua # (b)(4).A sample is available for evaluation.Upon completion of the investigation, 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.Confirmatory testing was performed using pcr test method and the result was negative.The customer stated they are testing asymptomatic staff members.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
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 0316883.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.H3 other text : see h10.
 
Event Description
It was reported while testing for sars-cov-2 a false positive result was obtained.Confirmatory testing was performed using pcr test method and the result was negative.The customer stated they are testing asymptomatic staff members.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).
 
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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 INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key11253985
MDR Text Key233018916
Report Number1119779-2021-00188
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/01/2021
Device Catalogue Number256082
Device Lot Number0316883
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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