MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-12-28 for MAGNAPURE LC SYSTEM MAGNA PURE 12236931001 manufactured by Roche Diagnostics.
[774146]
User experiencing cross contamination when using the magnapure lc sys. No specific data provided. The investigational unit was not able to identify the root cause to this problem. It was noted, the customer is using non specified sample material, the customer has reported reagent splattering, and the customer does not use ung to eliminate contaminations by pcr prods.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2007-11156 |
| MDR Report Key | 971574 |
| Report Source | 05,06 |
| Date Received | 2007-12-28 |
| Date of Report | 2007-12-28 |
| Date of Event | 2007-03-05 |
| Date Facility Aware | 2007-03-05 |
| Report Date | 2007-03-05 |
| Date Mfgr Received | 2007-03-05 |
| Date Added to Maude | 2008-04-10 |
| 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 | 3 |
| Manufacturer Contact | SALLY BOWDEN |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214668 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNAPURE LC SYSTEM |
| Generic Name | NUCLEIC ACID ISOLATION SYSTEM - |
| Product Code | LNJ |
| Date Received | 2007-12-28 |
| Model Number | MAGNA PURE |
| Catalog Number | 12236931001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 974208 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-28 |