VIDAS INSTRUMENT 99011

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number3002769706-2005-00013
MDR Report Key592128
Report Source07
Date Received2005-04-08
Date of Report2005-04-08
Date of Event2005-03-10
Date Mfgr Received2005-03-16
Date Added to Maude2005-04-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMANDA KIRBY
Manufacturer Street100 RODOLPHE ST.
Manufacturer CityDURHAM NC 27712
Manufacturer CountryUS
Manufacturer Postal27712
Manufacturer Phone9196202053
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameVIDAS INSTRUMENT
Generic NameDISCRETE WAVELENGTH FLUROMETER
Product CodeJZT
Date Received2005-04-08
Model NumberNA
Catalog Number99011
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key581974
ManufacturerBIOMERIEUX, INC.
Manufacturer Address100 RODOLPHE ST. DURHAM NC 27712 US
Baseline Brand NameVIDAS INSTRUMENT
Baseline Generic NameDISCRETE WAVELENGTH FLUROMETER
Baseline Model NoNA
Baseline Catalog No99011
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-04-08

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