MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-05-24 for VIDAS W2010 manufactured by Biomerieux, Inc..
[17773230]
The customer called to report that they were having problems with patient results. A field service engineer was sent to the site at which time the instrument failed a pump diagnostic test (oct test). The pump was replaced and the old pump was confirmed to have a clogged pump tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2001-00009 |
| MDR Report Key | 335400 |
| Report Source | 01 |
| Date Received | 2001-05-24 |
| Date of Report | 2001-05-22 |
| Date of Event | 2001-03-19 |
| Date Mfgr Received | 2001-03-19 |
| Device Manufacturer Date | 1991-12-01 |
| Date Added to Maude | 2001-06-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA PERREAND |
| Manufacturer Street | 595 ANGLUM DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS |
| Generic Name | IMMUNOFLUROMETRIC EQUIPMENT |
| Product Code | JZT |
| Date Received | 2001-05-24 |
| Model Number | NA |
| Catalog Number | W2010 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 324747 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 595 ANGLUM DRIVE HAZELWOOD MO 63042 US |
| Baseline Brand Name | VIDAS |
| Baseline Generic Name | IMMUNOFLUOROMETER EQUIPMENT |
| Baseline Model No | NA |
| Baseline Catalog No | W2010 |
| Baseline ID | NA |
| Baseline Device Family | VIDAS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K923579 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-05-24 |