MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-31 for COBAS 4800 BRAF V600 MUTATION TEST 05985595190 manufactured by Roche Molecular Systems.
[71463676]
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 w09521 used in testing on (b)(6) 2017. Another mdr is filed for the reagent lot w12410 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)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71463677]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2017-00008 |
| MDR Report Key | 6450743 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-31 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 4800 BRAF V600 MUTATION TEST |
| Generic Name | SOMATIC GENE MUTATION DETECTION SYSTEM |
| Product Code | OWD |
| Date Received | 2017-03-31 |
| Model Number | NA |
| Catalog Number | 05985595190 |
| Lot Number | W09521 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-31 |