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..
[16267498]
Customer called mfr's support department to report false negative rubella test results on the vidas instrument when the assay was run in one of the instrument's 30 positions, specifically section b, channel 5. Field service was dispatched and replaced the pump in that position. Further analysis of the pump indicates that the tubes within the pump were clogged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2001-00005 |
| MDR Report Key | 331767 |
| Report Source | 01 |
| Date Received | 2001-05-08 |
| Date of Report | 2001-05-08 |
| Date of Event | 2001-02-28 |
| Date Mfgr Received | 2001-02-28 |
| Device Manufacturer Date | 1992-02-01 |
| 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 | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS |
| Generic Name | IMMUNOFLUROMETER 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 | 321136 |
| 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 |