MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-05 for COBAS AMPLICOR CHLAMYDIA TACHOMATIS TEST 20757497122 manufactured by Roche Molecular Systems.
[9551497]
(b)(4). No failure detected and product within specifications. Upon investigation there was no trend found in the field. Qc release data for the kit batches met specifications. No internal non-conformances have been generated for kit batch p08563. No product or batch non-conformance was identified. Investigative testing of retain kits met qc specifications and did not reproduce customer's allegation. Additionally, the controls for each customer run were valid. The customer was using a non-validated sample type and stated that they were using a 'modified' sample extraction procedure. As all samples were extracted during the modified extraction procedure at the customer site, this type of deviation from the package insert can affect the performance of the test. For reliable test results, the customer should follow instructions for proper specimen collection. This test is not intended for use with throat, rectal, or types of specimens other than those specified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15579891]
A customer site in the united states alleged that discrepant results were generated with the cobas amplicor chlamydia trachomatis test. Specifically, the customer stated that they generated a discrepant result for one patient sample. The customer re-ran a (b)(6) sample (sample was originally tested with the cobas amplicor chlamydia trachomatis test) on a different cobas amplicor analyzer and generated a (b)(6) result. The customer was using off label sample collection media. The controls were valid for both runs.
Patient Sequence No: 1, Text Type: D, B5
[15867395]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00102 |
| MDR Report Key | 2357418 |
| Report Source | 05 |
| Date Received | 2011-12-05 |
| Date of Report | 2012-02-08 |
| Date of Event | 2011-11-10 |
| Date Mfgr Received | 2012-02-08 |
| Date Added to Maude | 2011-12-05 |
| 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 | 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLICOR CHLAMYDIA TACHOMATIS TEST |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2011-12-05 |
| Catalog Number | 20757497122 |
| Lot Number | P03064 |
| 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 | 2011-12-05 |