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

Catalog Number 07248563190

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is ongoing and a supplemental mdr will be submitted to share the conclusions.Initial reporter: (b)(6).(b)(4).

Event Description

A customer from (b)(6) alleged a high number of ex20ins positive results using two lots of the cobas egfr mutation test v2 since (b)(6) 2021.A review of the data identified a total of 6 generated ex20ins positive results.No apparent harm or injury was indicated in relation to the event.An investigation is ongoing.Two (2) mdrs will be filed, one for each of the reagent lot used.

Manufacturer Narrative

Roche identified that a customer outside of the united states was using a non-commercial egfr tissue asap version (cobas® egfr tissue asap v1.0.0.1512), which is a pre-launch version that was never commercialized.The customer should have been using the commercial tissue asap version: cobas® egfr tissue p1 ap version 1.0.0.1560 (launched 2015).In the customer¿s data, (b)(4) samples were identified with a "mutation detected" result for the ex20ins mutation using the non-commercial tissue asap (v1.0.0.1512); if the customer was using the commercialized tissue asap (v1.0.0.1560), the questioned results would have been reported as "no mutation detected" for the ex20ins mutation.No impact is expected for other egfr mutations reported by the cobas® egfr mutation test v2, including ex19del, g719x, s768i, t790m, and l861q.It is to be noted that the ex20ins "mutation detected" results were not reported out; rather, they were reported as "indeterminate".Also, the customer had the commercialized tissue asap (v1.0.0.1560) installed on its system in (b)(6) 2022.The use of the non-commercial tissue asap is not likely to cause serious adverse health consequences.Customers were previously instructed in august 2021 to confirm ex20ins "mutation detected" results generated with the cobas® egfr mutation test v2 with another orthogonal method (e.G., sequencing or other pcr-based tests) before releasing the final test reports.If the confirmatory testing is performed as instructed at the customer¿s sites, the use of cobas® egfr mutation test v2 with the non-commercial tissue asap version v1.0.0.1512 for ex20ins mutation detection will be not likely to cause adverse events in the affected patient population.Current information suggests that this situation is unique to a single overseas country.The relevant roche affiliate organization will be notified to ensure all customers in that country are using the commercial asap and that any local copies of the non-commercial asap are quarantined and locally destroyed, immediately.Added info in b6 and updated date of event to earliest run date.Added b14 analysis of production records and b11 historical data analysis.

• 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 Key: 13091239
• MDR Text Key: 290792489
• Report Number: 2243471-2021-03930
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P150047
• Number of Events Reported: 1
• 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: 06/14/2022

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 Date: 09/30/2022
• Device Catalogue Number: 07248563190
• Device Lot Number: G25391
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/14/2022
• 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 Number: 1