MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-08-30 for PROFIBLOT II N 16059001 manufactured by Tecan Austria Gmbh.
[683774]
Patient western blot test result was reported to the physician as positive. The physician requested the western blot test be repeated. The repeated western blot sample test result was negative.
Patient Sequence No: 1, Text Type: D, B5
[7863810]
This event is being investigated and a 30 day follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002710220-2007-00001 |
| MDR Report Key | 906853 |
| Report Source | 07 |
| Date Received | 2007-08-30 |
| Date of Report | 2007-08-30 |
| Date of Event | 2007-08-03 |
| Date Facility Aware | 2007-08-08 |
| Report Date | 2007-08-23 |
| Date Reported to Mfgr | 2007-08-23 |
| Date Mfgr Received | 2007-08-08 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 2007-10-18 |
| 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 | 3 |
| Manufacturer Contact | MR. BERNHARD WALTER |
| Manufacturer Street | 1A UNTERSBERGSTRASSE |
| Manufacturer City | GROEDIG SALZBURG 5082 |
| Manufacturer Country | AU |
| Manufacturer Postal | 5082 |
| Manufacturer Phone | 2468933198 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROFIBLOT II N |
| Generic Name | VARIOUS WESTERN BLOT PROCESSOR |
| Product Code | MVW |
| Date Received | 2007-08-30 |
| Returned To Mfg | 2007-08-27 |
| Model Number | 16059001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 900013 |
| Manufacturer | TECAN AUSTRIA GMBH |
| Manufacturer Address | GROEDIG SALZBURG AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-30 |