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..
[191116]
A field service engineer was dispatched to the site as part of a worldwide check for clogged pump tubes on the vidas instrument. During one such visit to the customer below by biomerieux field service engineer the instrument failed performance testing which indicated that the pump in the failing position could be clogged. The pump was further analyzed and it was determined that it was clogged. A clogged pump tube can result in inaccurate test results being reported by the laboratory. The pump was replaced by the field service engineer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2001-00008 |
| MDR Report Key | 335405 |
| Report Source | 01 |
| Date Received | 2001-05-24 |
| Date of Report | 2001-05-22 |
| Date of Event | 2001-03-21 |
| Date Mfgr Received | 2001-03-21 |
| Device Manufacturer Date | 1992-04-01 |
| 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 | 3147318594 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| 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 | 324752 |
| 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 |