MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-04-08 for VIDAS INSTRUMENT 99011 manufactured by Biomerieux, Inc..
[18831475]
A false value was reported on the vidas digoxin assay. The false results was due to a pump seal incorrectly positioned thus causing a pipetting error. The patient was already on digoxin therapy and the incorrect result did not affect or alter the patient's therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00013 |
| MDR Report Key | 592128 |
| Report Source | 07 |
| Date Received | 2005-04-08 |
| Date of Report | 2005-04-08 |
| Date of Event | 2005-03-10 |
| Date Mfgr Received | 2005-03-16 |
| Date Added to Maude | 2005-04-19 |
| 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 FLUROMETER |
| Product Code | JZT |
| Date Received | 2005-04-08 |
| Model Number | NA |
| Catalog Number | 99011 |
| 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 | 581974 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST. DURHAM NC 27712 US |
| Baseline Brand Name | VIDAS INSTRUMENT |
| Baseline Generic Name | DISCRETE WAVELENGTH FLUROMETER |
| Baseline Model No | NA |
| Baseline Catalog No | 99011 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-08 |