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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 Problems False Positive Result (1227); Non Reproducible Results (4029)
Patient Problems Solid Tumour (4552); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
An investigation is ongoing.A supplemental report will be filed upon completion of the investigation.(b)(4).
 
Event Description
A customer from (b)(6) alleged 22 samples generated discrepant results for ex20ins when tested with the cobas egfr mutation test v2, lots g18263 and g25391.Twenty (20) samples generated ex20ins mutation detected results in the initial tests.Retests generated no-mutation-detected results.Two additional samples generated ex20ins mutation detected results in the original and repeat testing.Sequencing analysis (amoydx) generated negative results.Only data for 4 of the alleged samples were provided.No harm was alleged.An investigation is ongoing.
 
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 will be 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).Updated to reflect data provided and samples identified.Updated patient codes.Changed device codes from non reproducible results to false positive (b)(4).
 
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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
MDR Report Key12173581
MDR Text Key281590783
Report Number2243471-2021-02501
Device Sequence Number1
Product Code OWD
UDI-Device Identifier00875197005448
UDI-Public00875197005448
Combination Product (y/n)N
PMA/PMN Number
P150047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/16/2021
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 Date02/28/2022
Device Catalogue Number07248563190
Device Lot NumberG18263
Initial Date Manufacturer Received 06/16/2021
Initial Date FDA Received07/15/2021
Supplement Dates Manufacturer Received08/24/2021
Supplement Dates FDA Received09/16/2021
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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