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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR; CORONAVIRUS ANTIGEN DETECTION SYSTEM
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR; CORONAVIRUS ANTIGEN DETECTION SYSTEM Back to Search Results
Catalog Number 256089
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 01/17/2021
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 7 false positive results were obtained.Repeat tests were performed using pcr and the results were 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 not reported out so 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 ce (material # 256089), batch number 0311781.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 and testing were performed on the batch number provided.The reported issue was unable to be confirmed.Photos were returned and reviewed.The problem could not be confirmed from the photographs provided.However, there is a trend against false positive results.Bd has initiated capa (corrective and preventive action) #1878253 to further investigate.Bd quality will continue to closely monitor for trends.
 
Event Description
It was reported while testing for sars cov-2 7 false positive results were obtained.Repeat tests were performed using pcr and the results were 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 not reported out so there was no report of patient impact.Eua#: 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)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH 
MDR Report Key11308703
MDR Text Key234288284
Report Number3006948883-2021-00210
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/06/2021
Device Catalogue Number256089
Device Lot Number0311781
Was Device Available for Evaluation? No
Date Manufacturer Received10/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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