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 |