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: BECTON, DICKINSON & CO. (SPARKS) BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM; SARS-COV-2 REAGENT KIT
  • 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
 

BECTON, DICKINSON & CO. (SPARKS) BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM; SARS-COV-2 REAGENT KIT Back to Search Results
Catalog Number 444213
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
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 while testing for sars cov-2 false positive results were obtained.The samples were recollected and repeated using an unspecified test method and the results were negative.There was no indication that results were reported out or any report of patient impact.Eua (b)(4).
 
Event Description
It was reported while testing for sars cov-2 false positive results were obtained.The samples were recollected and repeated using an unspecified test method and the results were negative.There was no indication that results were reported out or any report of patient impact.(b)(4).
 
Manufacturer Narrative
Investigation: the complaint investigation for discrepant result when using biogx sars-cov-2 osr for bd max system (ref 444213) lot k20-388 was performed by the review of the manufacturing records, review of customer¿s data and verification of complaints history.The investigation was conducted by bd and biogx and data analysis has revealed that the kit biogx sars-cov-2 osr was tested along with the extraction kit bd max exk tna-3 lot 0231382.Review of the manufacturing records of bd max exk tna-3 lot 0231382 indicated that the lot was manufactured according to specifications and met performance requirements.Biogx review of the manufacturing records indicated that biogx sars-cov-2 osr lot k20-388 shows acceptable performance characteristics.Customer reported false positive results on 2 patient samples with biogx sars-cov-2 osr for bd max system assay but both samples gave a negative result when tested with another assay.Customer provided one run (#359) from the database instrument ct1769 for investigation.The customer¿s udp settings were verified and the result logic parameters were set in accordance with the biogx sars cov-2 package insert instruction for use.Run #359 contains three positives results samples.Manual pcr curve adjudication was conducted.Manual curve adjudication has limitations; visual examination of pcr curves for low signal and/or aberrant curve geometry is an extremely conservative assessment of the data.Analysis of one of three positive results shows a pcr curve consistent with a high viral load while the two others show a weak amplification, suggesting that they probably correspond to the two discrepant results, but no information was provided to confirm it.All pcr curves from the three positive results show sigmoidal curves with a high endpoint value (more than 1000), suggesting true amplifications.If the two discrepant samples are associated to the two samples with a weak ct, the potential root cause could be low positive samples.Low positive samples can occur due to viral titers in the specimen being at or near the limit of detection (lod) of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.No product issue is suspected.There is no indication of an increase in complaints for discrepant result for biogx sars-cov-2 osr lot k20-388.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
Type of Device
SARS-COV-2 REAGENT KIT
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key11008141
MDR Text Key223179663
Report Number1119779-2020-01211
Device Sequence Number1
Product Code QJR
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/06/2021
Device Catalogue Number444213
Device Lot NumberK20-388
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-