MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-11-15 for COBAS AMPLICOR CT/NG TEST FOR C. TRACHOMATIS * 20757535122 manufactured by Roche Molecular Systems, Inc..
[535362]
Customer reported a period of specimens that were negative for chlamydia trachomatis with the roche molecular systems cobas amplicor ct/ng test, but positive with an alternate method.
Patient Sequence No: 1, Text Type: D, B5
[7914844]
The customer provided roche molecular systems with samples from the specimen in question. Roche molecular systems, inc. Investigated the customer's allegations and confirmed that the specimens tested negative for chlamydia trachomatis. Further investigation determined that the specimens contained a mutated strain of c. Trachomatis. This mutation resulted in the deletion of approximately 350 base pairs from the region within the cryptic plasmid dna covered by the test's primers / and or probe. Rms is continuing our investigation to better understand the provalence, and geographic distribution of the mutated strain. The package insert will also be modified to reflect the rare, but possible occurrence of mutations that could impact the test's performance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2006-00012 |
| MDR Report Key | 781491 |
| Report Source | 01 |
| Date Received | 2006-11-15 |
| Date of Report | 2006-10-13 |
| Date Mfgr Received | 2006-10-20 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 2006-11-17 |
| 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 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLICOR CT/NG TEST FOR C. TRACHOMATIS |
| Generic Name | IN VITRO DIAGNOSTIC NUCLEIC ACID TEST |
| Product Code | MKZ |
| Date Received | 2006-11-15 |
| Model Number | * |
| Catalog Number | 20757535122 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 769276 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | * BRANCHBURG NJ 08876 US |
| Baseline Brand Name | COBAS AMPLICOR CT NG |
| Baseline Generic Name | IN VITRO DIAGNOSTIC, NAT |
| Baseline Model No | * |
| Baseline Catalog No | 20757535122 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-15 |