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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 False Positive Result (1227)
Patient Problems Solid Tumour (4552); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2022
Event Type  malfunction  
Manufacturer Narrative
Roche received complaints from customers reporting the generation of false mutation detected results for the exon 20 insertion (ex20ins) mutation when using the cobas® egfr mutation test v2.During in-house testing using customer-provided ffpet samples, an ex20ins false mutation detected result was reproduced for one out of 8 ffpet samples, which was processed following the validated sample preparation method from the instructions for use.Although the majority of cases reported were from users using ffpet samples, the generation of false mutation detected ex20ins results with plasma specimens was reported in one case.A false mutation detected ex20ins result could lead to harm under specific scenarios.Consignees have been notified of the issue with instruction to follow the instructions for use for sample input requirements.Additionally, if an ex20ins mutation detected result is generated with the cobas® egfr mutation test v2, customers must confirm the result with another method (e.G., sequencing or other pcr-based tests).
 
Event Description
A customer from spain alleged discrepant results with 1 patient sample using the cobas® egfr mutation test v2.The alleged sample was initially tested with the cobas® egfr mutation test v2 and generated a "mutation detected" result for exon20ins.The same sample was retested using next generation sequencing (ngs) and generated a "mutation not detected" result.The cobas egfr assay result was not reported to the patient and no harm was alleged.
 
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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
timothy blair
1080 us hwy 202 s
building 500, room: 3530
branchburg, NJ 08876
9253534412
MDR Report Key16210519
MDR Text Key309299548
Report Number2243471-2023-00051
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
Remedial Action Notification
Type of Report Initial
Report Date 01/19/2023
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 NumberJ02054
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/27/2022
Initial Date FDA Received01/19/2023
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
Removal/Correction Number2243471-08-24-2021-003-C
Patient Sequence Number1
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