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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS EGFR TEST V2; SOMATIC GENE MUTATION DETECTION SYSTEM

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ROCHE MOLECULAR SYSTEMS, INC. COBAS EGFR TEST V2; SOMATIC GENE MUTATION DETECTION SYSTEM Back to Search Results
Catalog Number 07248563190
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2021
Event Type  malfunction  
Event Description
A customer from (b)(6) alleged discrepant results for multiple samples.Cobas egfr test detected mutations, including double mutations (ex19del, l858r), and sanger sequencing and rotogene did not.The customer is running off-label, using 30um instead of 5 um of section of tissue sample.Per the instructions for use, only nsclc ffpet sections of 5-um thickness containing at least 10% tumor content by area are to be used in the cobas egfr test, v2.0.No harm or injury was indicated.Two mdrs will be filed.
 
Manufacturer Narrative
Investigation is ongoing.A follow-up report will be filed upon the completion of the investigation.(b)(4).
 
Manufacturer Narrative
No kit issues were identified during the course of the investigation.Performance testing of the complaint kit batch f25967 was performed and all results were valid and the kit met validation and acceptance criteria.It is possible that the discrepancies observed are caused by a combination of any of these factors, including but not limited to the customer's off-label workflow, differences between technologies, or ctr at the lod of the assay.(b)(4).
 
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Brand Name
COBAS EGFR TEST V2
Type of Device
SOMATIC GENE MUTATION DETECTION SYSTEM
Manufacturer (Section D)
ROCHE MOLECULAR SYSTEMS, INC.
1080 us highway 202 south
branchburg NJ 08876
MDR Report Key11329731
MDR Text Key280452005
Report Number2243471-2021-00336
Device Sequence Number1
Product Code OWD
Combination Product (y/n)N
PMA/PMN Number
P120019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/16/2021
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 Health Professional
Device Expiration Date09/30/2021
Device Catalogue Number07248563190
Device Lot NumberF25967
Initial Date Manufacturer Received 01/18/2021
Initial Date FDA Received02/15/2021
Supplement Dates Manufacturer Received03/11/2021
Supplement Dates FDA Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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