MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-09-30 for AMPLICHIP CYP450 TEST * 04591402190 manufactured by Roche Molecular Systems.
[428085]
The customer was using the rms amplichip cyp450 kit. Out of approximately 83 samples of known genotype, one was reported as discrepant when compared to three other genotyping platforms. The rms amplichip generated a genotype result of 2d6 *1/*41 and the other platforms generated a 2d6 *3/*4 genotype. Genotype 2d6 *1/*41 is associated with a phenotypic expression of an extensive metabolizer and genotype 2d6 *3/*4 with a phenotypic expression of a poor metabolizer. These results are part of an evaluation study and therefore had no impact on pt treatment. Treatment was neither recommended nor changed based on these results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2005-00024 |
| MDR Report Key | 645640 |
| Report Source | 05,07 |
| Date Received | 2005-09-30 |
| Date of Report | 2005-08-30 |
| Date Mfgr Received | 2005-09-01 |
| Date Added to Maude | 2005-11-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PIGOZZI |
| Manufacturer Street | 1080 US HIGHWAY 202 |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICHIP CYP450 TEST |
| Generic Name | MICRO ARRAY, IN VITRO DIAGNOSTIC |
| Product Code | NTI |
| Date Received | 2005-09-30 |
| Model Number | * |
| Catalog Number | 04591402190 |
| Lot Number | G01491 |
| ID Number | NA |
| Device Expiration Date | 2005-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 635147 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | * BRANCHBURG NJ * US |
| Baseline Brand Name | AMPLICHIP CYP450 TEST |
| Baseline Generic Name | MICRO ARRAY, IN VITRO DIAGNOSTIC |
| Baseline Model No | * |
| Baseline Catalog No | 04591402190 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-30 |