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 527001-6903 manufactured by Biomerieux, Inc..
[16029917]
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 h. Pylori assay result produced a false negative. The vidas h. Pylori assay is an assay for the detection of igc antibodies to helicobacter pylori. This false result was reported to the physician. However, no adverse effects on treatment of the pt occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00010 |
| MDR Report Key | 586124 |
| Report Source | 07 |
| Date Received | 2005-03-23 |
| Date of Report | 2005-03-23 |
| Date of Event | 2005-03-04 |
| 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 | 527001-6903 |
| 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 | 575972 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | VIDAS INSTRUMENT |
| Baseline Generic Name | DISCRETE WAVELENGTH FLUOROMETER |
| Baseline Model No | NA |
| Baseline Catalog No | 527001-6903 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-23 |