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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
Model Number 256066
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 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
Eua # : (b)(4).Medical device expiration date: na.Initial reporter address: the initial reported address was not provided.The bd (b)(4) address is being used fda notified: the initial reporter also notified the fda on november 18, 2020, via medwatch # 5097962.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that while using bd veritor plus analyzer with bd rapid detection of sars-cov-2 veritor" a false negative result was obtained.A repeat test was performed using a pcr test method and the result was positive.The patient tested was asymptomatic.This test is not intended for use on asymptomatic patients, and was therefore used off label.Results were reported to the fda under medwatch#: 5097962.There was no report of patient impact.
 
Manufacturer Narrative
The following fields have been updated/changed to reflect corrected information.Brand name: bd rapid detection of sars-cov-2 veritor¿.Medical device type: qkp.
 
Event Description
It was reported that while using bd veritor plus analyzer with bd rapid detection of sars-cov-2 veritor¿ a false negative result was obtained.A repeat test was performed using a pcr test method and the result was positive.The patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were reported to the fda under medwatch 5097962.There was no report of patient impact.
 
Event Description
It was reported that while using bd veritor plus analyzer with bd rapid detection of sars-cov-2 veritor¿ a false negative result was obtained.A repeat test was performed using a pcr test method and the result was positive.The patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were reported to the fda under medwatch 5097962.There was no report of patient impact.
 
Manufacturer Narrative
Investigation summary: the complaint was created for false positives on the bd veritor plus analyzer (p/n 256066, s/n (b)(6)).The customer reported that veritor analyzer only produces negative results.The device history record for bd veritor plus analyzer, sn (b)(6), was examined and showed no discrepancies relate to this issue that can be correlated to this complaint.The reader passed all tests including the final assembly process, oqa, source inspection, functionality, and final packing test and manual inspection.The bd veritor plus analyzer was not returned for investigation.Root cause for this issue is unable to be determined.This complaint is unconfirmed for an instrument failure.
 
Manufacturer Narrative
The following field was updated due to corrected information: h.6.Imdrf annex g grid: g01003 device ingredient or reagent.H.6.Investigation: this statement summarizes the investigation results regarding the complaints that alleges false negative or discrepant results when using kit bd veritor for rapid detection of sars-cov-2 (material # 256082), batch number 0232876.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.Investigation and testing were performed on the batch numbers 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 h.10.
 
Event Description
It was reported that while using bd veritor plus analyzer with bd rapid detection of sars-cov-2 veritor¿ five (5) false negative results were obtained.Repeat tests were performed using a pcr test method and the results were positive.The patients tested were symptomatic.Results were reported to the fda under medwatch 5097962.There was no report of patient impact.
 
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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 Key11084496
MDR Text Key224074250
Report Number1119779-2020-01276
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00382902560661
UDI-Public00382902560661
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,Followup,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number256066
Device Catalogue Number256066
Was Device Available for Evaluation? No
Date Manufacturer Received10/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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