MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS COBAS 4800 BRAF V600 MUTATION TEST; SOMATIC GENE MUTATION DETECTION SYSTEM

Catalog Number 05985595190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

A customer from (b)(6) alleged discrepant results received from the cobas braf mutation test and a sequencing test.A positive result was seen during a braf genotyping test with qpcr and sequencing.However, a no mutation detected result was generated when testing twice with the cobas 4800 braf v600 mutation test on (b)(6) 2017.The affiliate indicated because of the different results obtained from the braf mutation test and the sequencing test, the patient did not yet receive treatment.Review of the provided data on the cobas braf mutation test showed no ct values were seen for the mutant target.The wild-type (wt) ct values in both initial and repeat test showed delayed ct values that indicate a poor quality sample.As the wt ct value for the initial and repeat run indicate a poor quality sample and the controls were valid and within range, the issue at the site is likely sample specific.It is possible that the alleged sample is at the limit of detection (lod) of the test, the dna is highly degraded or has high amount of melanin in it (if it is skin sample because it interferes in pcr); therefore, the test would be difficult to detect the mutation.In addition, it is not known what frequency of mutation was observed in the sequencing test as the frequency of mutation might also affect the detection of mutation in a sample.Internal investigation on the complaint kit lots (w09521 and w12410) found the kit lots to meet specifications with no product problem found as no related non conformance was found in qc release data and no complaint trend was observed for these complaint kit lots.Medical affairs indicated that the risk of a false negative is that the patient won't be treated with vemurafinib or vem/tremetininb which could potentially prolong their life by 8-16 months depending upon the therapy.They would then be treated with other immunotherapy drugs such as pemborlizumab, but it would have an impact on survival as chemotherapy has it's toxicities and will only provide a few months of survival at best.However, if the mutation frequency is very low, it is unknown how effective v600e directed therapy would be.This mdr is filed for the reagent lot w12410 used in testing on (b)(6) 2017.Another mdr is filed for the reagent lot w09521 used in testing on (b)(6) 2017.The udi for the kit c4800 braf v600e amp/det 24t ce-ivd is (b)(4).The corresponding us kit material number is (b)(4) and its udi number is (b)(4).The facility name of the initial reported was truncated due to character limitations.The complete facility name is (b)(4).(b)(4).

Event Description

A patient from (b)(6) alleged discrepant results received from the cobas braf mutation test and a sequencing test.A positive result was seen during a braf genotyping test with qpcr and sequencing.However, a no mutation detected result was generated when testing twice with the cobas 4800 braf v600 mutation test on (b)(6) 2017 with 2 different reagent lots.The affiliate indicated because of the different results obtained from the braf mutation test and the sequencing test, the patient did not yet receive treatment.

• Brand Name: COBAS 4800 BRAF V600 MUTATION TEST
• Type of Device: SOMATIC GENE MUTATION DETECTION SYSTEM
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 6451114
• MDR Text Key: 71467011
• Report Number: 2243471-2017-00009
• Device Sequence Number: 1
• Product Code: OWD
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P110020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 05985595190
• Device Lot Number: W12410
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/31/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other