MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-01-14 for COBAS EGFR MUTATION TEST 06471463190 manufactured by Roche Molecular Systems.
[5166207]
A customer site in (b)(6) filed a complaint alleging that a sample was identified as wild type (mutation not detected) but was expected to be a g719x mutant when using the cobas egfr mutation test, lot t05841. The sample was an ffpe panel sample. When the sample and slides were sent back to the sample provider, the provider confirmed the g719x mutation using the entrogen assay. A new extraction was performed and run with the cobas egfr mutation test at the customer site and again generated a mutation not detected result.
Patient Sequence No: 1, Text Type: D, B5
[12753102]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. Note: product code nqf was selected as the closest available code. Nqf is immunohistochemistry assay egfr. The product in this mdr is a nucleic acid test (nat) for egfr. Cobas egfr mutation test ivd udi (b)(4). The associated us product shares the same identification above. Pma p120019. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37868181]
Date additional information was received by the manufacturer: 13-feb-2015. Follow up report 1. Additional information/device evaluation. Device evaluated by manufacturer yes. (b)(4). A customer in (b)(6) alleged false mutation not detected g719x results for ffpet samples while performing a validation study with the cobas egfr mutation test; a competitor assay (entrogen) generated mutation detected results for g719x. The ffpet samples were returned and subjected to sequencing, which revealed wild-type mutations for egfr. As sequencing did not detect any g719x mutations, the mutation not detected results generated for the samples with the cobas egfr mutation test at the customer site are expected. Investigative testing was performed on the retain kit t05841 and met specifications. Based on the results of sequencing analysis and retain testing, no product malfunction was identified and the test performed as intended with the particular ffpet samples. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2015-00003 |
| MDR Report Key | 4419759 |
| Report Source | 01,05 |
| Date Received | 2015-01-14 |
| Date of Report | 2015-02-13 |
| Date of Event | 2014-12-10 |
| Date Mfgr Received | 2015-02-13 |
| Date Added to Maude | 2015-02-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS EGFR MUTATION TEST |
| Generic Name | EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE MUTATION / MRNA EXPRESSION IVD, NAT |
| Product Code | OWD |
| Date Received | 2015-01-14 |
| Catalog Number | 06471463190 |
| Lot Number | T05841 |
| Device Expiration Date | 2015-08-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-14 |