MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-19 for AMPLICHIP CYP450 TEST 04591402190 manufactured by Roche Molecular Systems.
[1547724]
The customer site reported that discrepant results were generated for a "rotating control" (previously tested patient sample) with the amplichip(b)(4) test. It is unknown if erroneous patient results were reported to physicians.
Patient Sequence No: 1, Text Type: D, B5
[1590743]
Update: the customer site indicated that no patient results were reported from test runs with an invalid control (roche control or customer external control).
Patient Sequence No: 1, Text Type: D, B5
[8657304]
No conclusion can be drawn at this time as the investigation into this issue is ongoing. Conclusion from the investigation will be submitted through a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[8754572]
Corrected / additional data: describe event or problem: updated, based on customer feedback, to indicate that no patient results were reported from invalid test runs. Device evaluated by manufacturer: updated to "no". Updated based on investigation conclusions. The complaint kit was not tested as it was determined, based on the evaluation of this issue, that the customer handling of the external controls (previously positive patient samples) lead to the issue observed. Method: evaluation of the customer's data and the customer's workflow. A customer site in the united states reported that miscall results for the cyp2d6 gene were generated with their external control and no call results were generated with the amplichip cyp450 positive control. The customer indicated that their external controls are previously extracted and tested patient samples that have been stored at -20 degrees c since 2007. No patient results were reported from test runs with either an invalid amplichip cyp450 positive control or the customer's external control. The amplichip cyp450 test is intended to identify a patient's cyp2d6 and cyp2c19 genotype from genomic dna extracted from a whole blood sample. Information about cyp2d6 and cyp2c19 genotype 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. The investigation into this issue determined that the customer was storing their external control off-label. As indicated within the product labeling, extracted genomic dna (undiluted and diluted) should be stored at 2 to 8 degrees c for up to one week or frozen at -20 degrees c for up to one month, with no more than three freeze-thaw cycles. Storing extracted dna improperly (i. E. , three years at -20 degrees c) leads to degradation and consequently poor amplification of the largest duplication and deletion amplicons. The investigation into this complaint did not identify any product performance issues with the amplichip cyp450 test or the specific complaint batches. Based on the available information, it was determined that the discrepant external control results observed by the customer were likely due to mishandling of the extracted genomic dna by the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00027 |
| MDR Report Key | 1694314 |
| Report Source | 05 |
| Date Received | 2010-05-19 |
| Date of Report | 2010-08-30 |
| Date of Event | 2010-04-12 |
| Date Mfgr Received | 2010-08-30 |
| Device Manufacturer Date | 2010-02-19 |
| Date Added to Maude | 2010-09-10 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | AMPLICHIP CYP450 TEST |
| Generic Name | DRUG METABOLIZING ENZYME GENOTYPING SYSTEMS |
| Product Code | NTI |
| Date Received | 2010-05-19 |
| Catalog Number | 04591402190 |
| Lot Number | M15616 |
| Device Expiration Date | 2010-11-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-05-19 |