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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

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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 06/22/2022
Event Type  malfunction  
Event Description
A customer from spain alleged discrepant results with one sample using with the cobas egfr mutation test v2.The alleged sample is from a patient who was previously diagnosed with the ex19del mutation in order to detect if any resistance mutations developed.When testing the sample from the first extraction of cfdna, the result was mutation detected for t790m mutation only.The customer repeated the cfdna extraction to re-test the sample.In this case, the result was mutation detected for ex19del, but the t790m mutation was not detected.Subsequently, a new blood collection was performed and the sample was re-tested in duplicate.The results were 1) ex19del and t790m mutations detected and 2) ex19del mutation detected and t790m was not detected.No harm or injury alleged.
 
Manufacturer Narrative
The investigation of the reagents did not show any product malfunction.The t790m mutation discrepancy is due to a low number of mutations in the sample; the ctr values are near the lod of the assay, which may cause varying results.The root cause of the mutation not detected (nan) in the initial run on (b)(6) 2022 for the ex19del is unknown.In all subsequent testing of the sample, the ex19del was present and generated robust ct values.The ex19del discrepancy could be related to workflow practices.
 
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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
stacie-ann creighton
1080 us hwy 202 s
na
branchburg, NJ 08876
9082537112
MDR Report Key15080163
MDR Text Key304716892
Report Number2243471-2022-00617
Device Sequence Number1
Product Code OWD
UDI-Device Identifier00875197005448
UDI-Public00875197005448
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 07/21/2022
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 Date04/30/2023
Device Catalogue Number07248563190
Device Lot NumberH14612
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/28/2022
Initial Date FDA Received07/21/2022
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
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