MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-22 for COBAS AMPLICOR CT/NG TEST 20759414122 manufactured by Roche Molecular Systems.
[1919082]
A customer site in united states reported that they received discrepant neisseria gonorrhoeae (ng) results when using the cobas amplicor ct/ng test. The customer site protocol is to repeat test all (b)(6) results , which is an off-label practice. The customer also indicated that they received discrepant chlamydia trachomatis (ct) results. The ct discrepant results are being addressed in mdr 2243471-2011-00038. On (b)(6) 2011, they obtained the following results for sample (b)(6). When repeated on (b)(6) 2011, the results were (b)(6). The (b)(6) result was reported to the physician. It is unknown if any patient treatment was affected.
Patient Sequence No: 1, Text Type: D, B5
[9120206]
Device evaluated by manufacturer - yes. Result: failure to service/maintain according to manufacturer's specification. Device failure related to maintenance. Off-label, unapproved or contraindicated use. During the investigation, it was learned that the site was rinsing the wash container reservoir with tap water and not allowing it to dry prior to preparing the wash buffer. The cobas amplicor analyzer operator's manual weekly maintenance procedures specify rinsing the wash reservoir with distilled or de-ionized water only. It is suspected that instrument contamination was introduced with the tap water rinsing of the reservoir, which led to an increase in grey zone and discrepant results. The increased grey zone results resolved after the customer instituted the change to distilled water rinsing. A subsequent follow up with the affiliate confirmed that the customer has not had any further issues with discrepant or increased grey zone results since the correct maintenance procedure at the site was instituted. For the discrepant results that were produced, it is unknown which results were correct since the customer performed initial and repeat testing on a potentially contaminated analyzer. Patient information was not provided and is not available no product non-conformance was identified, as the issue is attributed to an isolated, site specific issue caused by improper handling of the cobas amplicor analyzer wash reservoir. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9163640]
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
| Report Number | 2243471-2011-00044 |
| MDR Report Key | 2026657 |
| Report Source | 05 |
| Date Received | 2011-03-22 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-02-21 |
| Date Mfgr Received | 2011-03-01 |
| Date Added to Maude | 2011-06-06 |
| 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 | 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-REAGENTS, NEISSERIA |
| Product Code | LSL |
| Date Received | 2011-03-22 |
| Catalog Number | 20759414122 |
| 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 | 2011-03-22 |