MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-07 for AMPLICHIP CYP450 TEST, US-IVD 04591402190 manufactured by Roche Molecular Systems.
[1180714]
The customer reported that they generated discrepant results for a patient sample that was tested on two different dates with the amplichip cyp450 test, us-ivd. The customer indicated that no test results were reported as they observed the discrepancy prior to releasing results.
Patient Sequence No: 1, Text Type: D, B5
[1513419]
The customer indicated that the expected test result for the patient sample was *1/*1 for the cyp2d6 allelic variants.
Patient Sequence No: 1, Text Type: D, B5
[8320775]
Result codes and conclusion codes were updated to reflect the outcome of the complaint investigation. Investigation into this issue determined the following: -the customer was performing the test off-label as they were utilizing the incorrect dnase i reagent during testing, which may have contributed to the discrepant results that were generated. As per the product labeling, the customer must utilize dnase i, rnase-free recombinant, material (b) (4) (roche diagnostics). The customer did indicate that they were utilizing a roche dnase; however, they acknowledged that it was not the appropriate material number. -testing of retain material was performed and the retain material met product specifications. -testing of the customer-returned patient sample was performed as per the product labeling. The patient sample generated the expected result of *1/*1 for the (b) (4) allelic variants and *1/*1 for the (b) (4) allelic variants. -quality control release testing results were reviewed and were found to be within specification. -there was no product or batch non-conformance identified during a review of prior complaint cases. (b) (4)
Patient Sequence No: 1, Text Type: N, H10
[8414718]
Currently, this issue is being investigated and a more thorough conclusion will be drawn once the investigation has been completed. In accordance with the product labeling, the test is intended to provide information about the cpy2d6 and the cyp2c19 genotype that may be used as an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics that are metabolized by the cyp2d6 or cyp2c19 gene product. Additionally, the product labeling does not provide a retest algorithm for valid test runs, and therefore, retesting patient specimens is considered an off-label practice. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00015 |
| MDR Report Key | 1494202 |
| Report Source | 05 |
| Date Received | 2009-10-07 |
| Date of Event | 2009-09-02 |
| Date Mfgr Received | 2009-09-03 |
| Date Added to Maude | 2010-03-08 |
| 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 | 0 |
| Manufacturer Contact | MRS. LEXIE PIEPER |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537855 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICHIP CYP450 TEST, US-IVD |
| Generic Name | DRUG METABOLIZING ENZYME GENOTYPING SYSTEMS; PRODUCT CODE: N |
| Product Code | NTI |
| Date Received | 2009-10-07 |
| Catalog Number | 04591402190 |
| Lot Number | M04313 |
| Device Expiration Date | 2010-01-31 |
| 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 | 2009-10-07 |