Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 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 01/09/2021
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 2 discrepant results were obtained.The samples were repeated on the veritor and upon repeat the results changed.The customer removed and reinserted the positive test cartridge to repeat the test and the second result was negative.The cartridges are single use and should not be re-run, as indicated in the instructions for use.The customer stated a result was reported out, but there was no report of patient impact for either.Eua#: (b)(4).
 
Event Description
It was reported while testing for sars cov-2 2 discrepant results were obtained.The samples were repeated on the veritor and upon repeat the results changed.The customer removed and reinserted the positive test cartridge to repeat the test and the second result was negative.The cartridges are single use and should not be re-run, as indicated in the instructions for use.The customer stated a result was reported out, but there was no report of patient impact for either.Eua#: eua (b)(4).
 
Manufacturer Narrative
H6: investigation summary: this statement summarizes the investigation results regarding your complaints that alleges false negative or discrepant results when using kit bd veritor for rapid detection of sars-cov-2 (material # 256082), batch number 0328057.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.An investigation and testing were performed on the batch number provided and no issue was found.The complaint was unable to be confirmed via the retain samples.The root cause could not be identified.A trend analysis for false negative or discrepant results was conducted, no adverse trend was identified.There were no corrective actions taken at this time.H3 other text: see h10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH  
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11282693
MDR Text Key230745700
Report Number3006948883-2021-00190
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/18/2021
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 Expiration Date04/17/2021
Device Catalogue Number256082
Device Lot Number0328057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/14/2021
Initial Date FDA Received02/04/2021
Supplement Dates Manufacturer Received11/18/2021
Supplement Dates FDA Received12/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-