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 W1020 manufactured by Biomerieux Inc..
[222852]
Customer in italy called to report that they were receiving incorrect results as the rfv values were near zero in position a2 on the instrument. Customer immediately placed section a offline and field service was dispatched. The pump was subsequently replaced by field service and the section was placed back in service. The customer does not believe any patient results were affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2001-00006 |
| MDR Report Key | 335479 |
| Report Source | 01 |
| Date Received | 2001-05-24 |
| Date of Report | 2001-05-21 |
| Date of Event | 2001-03-12 |
| Date Mfgr Received | 2001-03-12 |
| Device Manufacturer Date | 1991-10-01 |
| 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 | IMMUNOFLUROMETER EQUIPMENT |
| Product Code | JZT |
| Date Received | 2001-05-24 |
| Model Number | NA |
| Catalog Number | W1020 |
| 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 | 324826 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 595 ANGLUM DRIVE HAZELWOOD MO 63042 US |
| Baseline Brand Name | VIDAS |
| Baseline Generic Name | IMMUNOFLUROMETER EQUIPMENT |
| Baseline Model No | NA |
| Baseline Catalog No | W1020 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-05-24 |