MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-05-08 for VIDAS W2010 manufactured by Biomerieux, Inc..
[20515802]
A field service engineer was dispatched to the site as part of a worldwide check for clogged pumps on vidas instruments. During one such visit to the customer below by a biomerieux field service engineer the instrument failed performance testing which indicated that the pump in the failing position could be clogged. A clogged pump 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 | 1950204-2001-00004 |
MDR Report Key | 331768 |
Report Source | 01 |
Date Received | 2001-05-08 |
Date of Report | 2001-05-04 |
Date of Event | 2001-03-22 |
Date Mfgr Received | 2001-03-22 |
Device Manufacturer Date | 1991-10-01 |
Date Added to Maude | 2001-05-14 |
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 | 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 | 2001-05-08 |
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 | 321137 |
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 | 2001-05-08 |