MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-20 for COBAS AMPLICOR CT/NG TEST 20759902122 manufactured by Roche Molecular Systems.
[2285162]
A customer site in (b)(6) alleges that discrepant results were generated with the cobas amplicor ct/ng test. The customer site repeat tested (b)(6) results, which is an off-label practice. As per product labeling, a (b)(6) result should be reported. Roche does not recommend or support the repeating of (b)(6) results for the assay. Please note that the cobas amplicor ct/ng detection kit encompasses a number of reagent kits below are the kits that are used with this product: kit ampl ct/ng prep gen2 100t ivd m/n 20759414122, kit ca ct det gen 2 100 ivd m/n 20757497122, kit ca ng det 100 tests ivd m/n 20757535122.
Patient Sequence No: 1, Text Type: D, B5
[9315438]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21234329]
The customer alleged that discrepant results were generated with the cobas amplicor ct/ng test. The customer site repeat tested (b)(6) results, which is an off-label practice. As per product labeling, a valid result should be reported. Roche does not recommend or support the repeating of valid (b)(6) results for the assay. Although requested, no patient samples were returned for further investigation. Retain testing was not performed as no trend was identified. Additionally, the customer allegation was not seen in the product release data for the complaint kit lot and no internal non-conformances were identified, indicating that there is no evidence of a product issue associated with the complaint kit (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00093 |
| MDR Report Key | 2302659 |
| Report Source | 05 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-09-27 |
| Date of Event | 2011-09-20 |
| Date Mfgr Received | 2011-10-31 |
| Date Added to Maude | 2012-07-09 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLICOR CT/NG TEST |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2011-10-20 |
| Catalog Number | 20759902122 |
| Lot Number | P02319 |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-10-20 |