MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-03-23 for VIDAS INSTRUMENT UNK manufactured by Biomerieux, Inc..
[19961246]
The vidas instrument is a discrete wavelength fluorometer. The instrument has 5 sections with 6 positions per section. The positions operate mechanically independent of each other and each position contains a sample. The customer reported one position to be out of range when a quality control test was run. The customer then discovered that one vidas ft4 assay result was false. The vidas ft4 assay is an elisa assay for the determination of human free thyroxine (ft4) concentration. The test provided a result of 55 pmol/1 instead of 12. 74 pmol/1. This false result was reported to the physician. No adverse effects on treatment of the pt were reported to biomerieux.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00009 |
| MDR Report Key | 586110 |
| Report Source | 07 |
| Date Received | 2005-03-23 |
| Date of Report | 2005-03-23 |
| Date of Event | 2005-02-21 |
| Date Mfgr Received | 2005-03-04 |
| Date Added to Maude | 2005-03-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMANDA KIRBY |
| Manufacturer Street | 100 RODOLPHE ST. |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202053 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS INSTRUMENT |
| Generic Name | DISCRETE WAVELENGTH FLUOROMETER |
| Product Code | JZT |
| Date Received | 2005-03-23 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 575958 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-23 |