MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-11-03 for AMPLICHIP CYP450 TEST 04381866190 manufactured by Roche Molecular Systems.
[2292820]
A customer site in (b)(6) filed a complaint alleging discrepant results were obtained when using the amplichip cyp450 test. The sample was originally tested on (b)(6) 2009 and generated a result of *5*5 (poor metabolizer) for 2d6. In (b)(6) 2011, a breath test was done for this patient and these results did not fit with results of poor metabolizer. On (b)(6) 2011, two retests were done. The first was done with an eluate of the 2009 sample. The second retest was done with a new sample collection. The result was *1*1 (extensive metabolizer). It is not known at this time if that result is from the first or second retest. No patient treatment information is available.
Patient Sequence No: 1, Text Type: D, B5
[9383203]
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. Amplichip cyp450 us-ivd, product number 04591402190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9575848]
Date of follow-up information was received. Follow up report 1. Device evaluated by manufacturer yes. No product or batch non-conformance was identified. The patient samples were not requested back as they were stored for approximately 2 years, which is not supported by the amplichip package insert sample storage claims. Furthermore, a new collection of the patient samples involved could not be obtained. Upon investigation there was no trend found in the field. Qc release data for n12926 was reviewed and the issue of discrepant results has not been observed. There have not been any manufacturing non-conformance reports for batch n12926. There are a few factors that can lead to the customer's observations, including but not limited to dna degradation, sample contamination or sample mix-up. As the samples were stored significantly beyond the storage claims, it cannot be reliable. . (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00096 |
| MDR Report Key | 2321329 |
| Report Source | 01,05 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-10-05 |
| Date of Event | 2011-08-20 |
| Date Mfgr Received | 2011-12-13 |
| Device Manufacturer Date | 2010-02-19 |
| Date Added to Maude | 2012-07-12 |
| 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 | 2011-11-03 |
| Catalog Number | 04381866190 |
| Lot Number | N12926 |
| Device Expiration Date | 2011-09-01 |
| 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 | 2011-11-03 |