MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-03-01 for MINIVIDAS INSTRUMENT W2011 manufactured by Biomerieux, Inc..
[408801]
Teh minividas isntrument is a discrete wavelength fluorometer. The instrument has 5 sections with 6 positions per section. The positions operate mechanically independent of each other. The customer reported that since january 2005 all of their tests in position a6 have been negative which the customer says is unusual. Biomerieux distributes and instructs customers to use a qc test, qcv (quality control vidas) monthly. This customer had not been running the qcv test. The customer is no longer cooperating with biomerieux, however, no reports of false results have been made. Biomerieux has asked the customer to perform a retrospective analysis of the results from position a6 to confirm this, however, the customer has not communicated the results of the retrospective analysis to biomerieux.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00006 |
| MDR Report Key | 582251 |
| Report Source | 07 |
| Date Received | 2005-03-01 |
| Date of Event | 2005-02-04 |
| Date Mfgr Received | 2005-02-04 |
| Date Added to Maude | 2005-03-18 |
| 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 | MINIVIDAS INSTRUMENT |
| Generic Name | DISCRETE WAVELENGTH FLUOROMETER |
| Product Code | IZT |
| Date Received | 2005-03-01 |
| Model Number | NA |
| Catalog Number | W2011 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 572094 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | MINIVIDAS INSTRUMENT |
| Baseline Generic Name | DISCRETE WAVELENGTH FLUOROMETER |
| Baseline Model No | NA |
| Baseline Catalog No | W2011 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-01 |