MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-23 for ONCOMINE (TM) DX TARGET TEST A32441 A32441 (A PART OF A32451) manufactured by Life Technologies Corporation.
[101144344]
Catalog #: a32451 is the identifier used for customers to order the oncomine dx target test. It is considered a "lot managed sku" which is not held in inventory, but provides instruction regarding which products will ship for the customer order. The oncomine dx target test rna/dna panel is only shipped as part of catalog #: a32451, but for traceability purposes, has it's own product identifiers: oncomine dx target test rna/dna panel, catalog #: a32441, lot #: 1705001, (b)(4). Since the oncomine dx target test rna/dna panel can only be ordered as part of the oncomine dx target test (catalog #: a32451), the oncomine dx target test is considered the affected product in the field. The date received by manufacturer is considered february 13, 2018. This is the date the clinical relevance of the low oligonucleotide concentration became available. On february 13, 2018 information regarding possible false negatives or "no calls" in the field were reported by thermo fisher scientific r&d to the investigation team. February 13, 2018 is considered the date thermo fisher scientific became aware of a mdr reportable event. Manufacturer narrative: the root cause of the low oligonucleotide concentration in the oncomine dx target rna/dna panel (catalog #: a32441) has been determined to be the inadvertent addition of the deionized water during filling of the bulk rna oligo solution during the lot manufacturing process. Bulk oligo solution was thawed, vortexed and then centrifuged using a counterweight containing di water. The operator mistakenly poured di water from the counterweight into the fill reservoir instead of the bulk oligo solution to complete the pipetting and fill/finish process of the rna panel. Customers were notified of the issue on february 16, 2018 and instructed to review any patient test results obtained using the defective product. Customers were advised to retest patient samples which resulted in a "no call" or negative result for a ros1 variant using an alternative test method if one was not previously performed. Patients tested with the defective rna panel may be at risk for receiving a false negative result. Only patients with a ros1 variant (1%-2% of the patient population) would be at risk for a false negative result and possibly be excluded from treatment with xalkori.
Patient Sequence No: 1, Text Type: N, H10
[101144345]
An internal investigation of the oncomine dx target test rna/dna panel (lot# 1705001), a component of the oncomine dx target test, revealed a manufacturing error caused a low oligonucleotide concentration in the rna panel of the final product. The low oligonucleotide concentration may cause the oncomine dx target test to malfunction and produce no test results, or false negative test results to be reported to a clinician when the oncomine dx target test is being used to determine the presence of a ros1 gene variant in patients with non-small cell lung cancer (nsclc). Nsclc patients identified with a ros1 gene variant may be candidates for the drug xalkori (crizotinib). Clinical studies for xalkori showed that 66% of the study participants with nsclc that had spread to other parts of the body experienced lessened metastasis, shrunken tumors, or no signs of cancer. Individuals who were given xalkori also had a median time period of 18. 3 months before noticable tumor growth/metastasis occured. A false negative test result for a ros1 variant may exclude a patient from receiving xalkori and the possible therapeutic benefits of the drug. The product malfunction was discovered internally. No reports of product malfunction, patient death or serious injury was received from customers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003335080-2018-00001 |
| MDR Report Key | 7293259 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-02 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2018-02-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3175 STALEY ROAD |
| Manufacturer City | GRAND ISLAND NY 14072 |
| Manufacturer Country | US |
| Manufacturer Postal | 14072 |
| Manufacturer Phone | 7167743122 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3003335080-2018-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONCOMINE (TM) DX TARGET TEST |
| Generic Name | ONCOMINE DX TARGET TEST |
| Product Code | PQP |
| Date Received | 2018-02-23 |
| Model Number | A32441 |
| Catalog Number | A32441 (A PART OF A32451) |
| Lot Number | 1705001 |
| Device Expiration Date | 2018-02-20 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-23 |