• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® EGFR MUTATION TEST V2; SOMATIC GENE MUTATION 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
 

ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® EGFR MUTATION TEST V2; SOMATIC GENE MUTATION DETECTION SYSTEM Back to Search Results
Catalog Number 07248563190
Device Problem Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2022
Event Type  malfunction  
Manufacturer Narrative
An investigation is ongoing, a follow up report will be submitted to share the conclusions.Na.
 
Event Description
A customer from india alleged discrepant results for one patient when using cobas egfr mutation test v2.On (b)(6) 2022 a plasma sample was tested using cobas egfr mutation test v2 and generated an ex19del mutation detected result.On (b)(6) 2022, a tissue sample from the same patient was tested using cobas egfr mutation test v2 and ex19del mutation was not detected.No harm alleged to date.
 
Manufacturer Narrative
Data was provided and reviewed.A review of the growth curves showed no abnormalities.Furthermore, there was no sign of growth in the ex19del in the tissue sample.Controls were valid and internal controls generated robust results.The observed discrepancy is most likely due to the differences between the sample specimen types (tissue vs plasma).The plasma specimen represents the amount of mutations in the cell-free dna during the time of blood collection whereas tissue contains dna that was collected during biopsy.Although the tissue is considered a "golden standard", it is possible that the ffpet (tissue) slide used for testing did not contain any/very low amount of ex19del mutation whereas the cfdna contained more.In addition, there are differences in results calculations between plasma and tissue specimen types.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COBAS® EGFR MUTATION TEST V2
Type of Device
SOMATIC GENE MUTATION DETECTION SYSTEM
Manufacturer (Section D)
ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
1080 us highway 202 south
branchburg NJ 08876
Manufacturer (Section G)
ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
1080 us highway 202 south
na
branchburg NJ 08876
Manufacturer Contact
timothy blair
1080 us hwy 202 s
building 500, room: 3530
branchburg, NJ 08876
9253534412
MDR Report Key16628888
MDR Text Key312164079
Report Number2243471-2023-00169
Device Sequence Number1
Product Code OWD
UDI-Device Identifier00875197005448
UDI-Public00875197005448
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P150047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/06/2023
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 Health Professional
Device Expiration Date12/31/2023
Device Catalogue Number07248563190
Device Lot NumberJ05038
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2023
Initial Date FDA Received03/28/2023
Supplement Dates Manufacturer Received03/31/2023
Supplement Dates FDA Received06/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-