MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-03-09 for AMPLICHIP CYP450 TEST * 04591402190 manufactured by Roche Molecular Systems, Inc..
[613674]
Internal review within roche molecular systems determined the correct package insert (part number 04591445001-03 7/2006) for the amplichip cyp 450 test listed on unvalidated and incorrect part number for dnase i. The dnase is listed in the "other materials required" section as "dnase i roc. , rnase-free, p/n 04716 728 001 (roche applied science)". The dnase listed is of lower specific activity than the validated dnase and will result in incomplete digestion of dna amplicon. Incomplete digestion will most likely result in invalidation of the test run due to negative results (no call) for the kit positive control. Patient specimen will also most likely generate "no call" results. The incorrect package insert was first used in 2006.
Patient Sequence No: 1, Text Type: D, B5
[7971756]
Lots involve include: h10526 (exp. Date 02/28/2007), h13592 (exp. Date 08/31/2007), j00807 (exp. Date 10/31/2007), j00815 (exp. Date 10/31/2007).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2007-00001 |
| MDR Report Key | 856660 |
| Report Source | 00 |
| Date Received | 2007-03-09 |
| Date of Report | 2007-02-21 |
| Date Mfgr Received | 2007-02-26 |
| Date Added to Maude | 2007-05-30 |
| 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 | ROBERT PIGOZZI, DIRECTOR |
| Manufacturer Street | 4300 HACIENDA DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICHIP CYP450 TEST |
| Generic Name | DURG METABOLIZING ENZYME GENOTYING SYSTEM |
| Product Code | NTI |
| Date Received | 2007-03-09 |
| Model Number | * |
| Catalog Number | 04591402190 |
| Lot Number | H08499 |
| ID Number | * |
| Device Expiration Date | 2006-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 841235 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | * BRANCHBURG NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-09 |