MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1999-10-01 for AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS 83252/0753491 manufactured by Roche Molecular Systems, Inc..
[184647]
On september 2, 1999, the rms complaint office rec'd notification from the roche diagnostic affiliate office that two of their customers have reported that the amplicor ct/ng test for chlamydia trachomatis detection kits contained the wrong microwell detection plate. The complaint was confirmed by roche molecular systems by visual inspection of the returned product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247632-1999-00002 |
| MDR Report Key | 242983 |
| Report Source | 08 |
| Date Received | 1999-10-01 |
| Date of Report | 1999-09-27 |
| Date of Event | 1999-09-02 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 1999-10-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARIA FEIJOO |
| Manufacturer Street | 1080 US HIGHWAY 202 |
| Manufacturer City | SOMERVILLE NJ 088763771 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763771 |
| Manufacturer Phone | 9082537310 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
| Generic Name | IN VITRO DIAGNOSTIC TEST FOR CHLAMYDIA TRACHOMATIS |
| Product Code | MKZ |
| Date Received | 1999-10-01 |
| Model Number | NA |
| Catalog Number | 83252/0753491 |
| Lot Number | 13019 |
| ID Number | * |
| Device Expiration Date | 2000-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 235408 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 11 FRANKLIN AVENUE BELLEVILLE NJ 07109 US |
| Baseline Brand Name | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
| Baseline Generic Name | IN VITRO DIAGNOSTIC TEST FOR CHLAMYDIA TRACHOMATIS |
| Baseline Model No | NA |
| Baseline Catalog No | 83252/0753491 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-10-01 |