MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-01 for ION TORRENT? ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY A35864 manufactured by Life Technologies Corporation.
[129753557]
The ion torrent? Oncomine lung cell-free total nucleic acid (cftna) research assay is labeled "for research use only. Not for use in diagnostic procedures. " (ruo) no patient impact at the biocept site was reported, however, the manufacturer, thermo fisher scientific, is submitting this mdr due to a possible false positive result` for the t790m variant at the (b)(6) if the lab utilizes the ruo product to assess patient samples. The unit in question was not returned by the customer. However, a different unit from the same lot was internally investigated by the manufacturer. This investigation is ongoing. Thermo fisher scientific has initiated the recall process to remove units of ion torrent? Oncomine lung cell-free total nucleic acid (cftna) research assay lot #: 2025404 from the market. Affected customers have been contacted to stop use of the product.
Patient Sequence No: 1, Text Type: N, H10
[129753558]
A representative from (b)(6), met with a customer representative from (b)(4) to discuss technical issues regarding validation activities at the (b)(6). (b)(6) complained that a possible contaminant in the ion torrent? Oncomine lung cell-free total nucleic acid (cftna) research assay caused the genetic variant, t790m, to show positive in sample known to be negative for the variant. This was haulting the site's validation activities. No patient samples were being analyzed when the contamination was reported. The product was not used to determine treatment or diagnostic decisions. Ion torrent? Oncomine lung cell-free total nucleic acid (cftna) research assay is labeled "for research use only. Not for use in diagnostic procedures. " the product is not a cleared or approved medical device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003335080-2018-00002 |
| MDR Report Key | 8122601 |
| Date Received | 2018-12-01 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2018-12-01 |
| 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 | DR. KELLI TANZELLA |
| Manufacturer Street | 7335 EXECUTIVE WAY |
| Manufacturer City | FREDERICK MD 21704 |
| Manufacturer Country | US |
| Manufacturer Postal | 21704 |
| Manufacturer G1 | LIFE TECHNOLOGIES CORPORATION |
| Manufacturer Street | 7335 EXECUTIVE WAY |
| Manufacturer City | FREDERICK MD 21704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ION TORRENT? ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY |
| Generic Name | ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY |
| Product Code | OTV |
| Date Received | 2018-12-01 |
| Catalog Number | A35864 |
| Lot Number | 2025404 |
| Device Expiration Date | 2019-08-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE TECHNOLOGIES CORPORATION |
| Manufacturer Address | 7335 EXECUTIVE WAY FREDERICK MD 21704 US 21704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-01 |