MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-01-29 for COBAS EGFR MUTATION TEST 06471463190 manufactured by Roche Molecular Systems, Inc..
[4406948]
A customer site in taiwan filed a complaint alleging that discrepant results were generated with the cobas egfr mutation test, batch s06809. The customer tested two samples on (b)(6) 2013 and they both detected exon 20 insertions. They reran these two samples and the repeated results did not detect exon 20 insertions. This mdr is being filed for sample 2. Mdr 2243471-2014-00001 is filed for sample 1. The associated us product is m/n 06471463190 p120019.
Patient Sequence No: 1, Text Type: D, B5
[11805919]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00002 |
| MDR Report Key | 3843074 |
| Report Source | 01,05 |
| Date Received | 2014-01-29 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-20 |
| Date Mfgr Received | 2013-12-30 |
| Date Added to Maude | 2014-06-18 |
| 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 U.S. 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 | 2014-01-29 |
| Catalog Number | 06471463190 |
| Lot Number | S06809 |
| Device Expiration Date | 2014-09-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 U.S. HWY. 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-29 |