VIDAS W2010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-05-08 for VIDAS W2010 manufactured by Biomerieux, Inc..

Event Text Entries

[20766206] Customer ran a positive control in channel 1 of the vidas instrument. The positive control failed and the customer called biomerieux to report the problem. The customer was advised to put the affected bay off-line. Field service went to the site and confirmed that the pump was not functioning and it was replaced in the affected channel.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2001-00003
MDR Report Key331771
Report Source01
Date Received2001-05-08
Date of Report2001-05-04
Date of Event2001-03-21
Date Mfgr Received2001-03-21
Device Manufacturer Date1991-06-01
Date Added to Maude2001-05-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSANDRA PERREAND
Manufacturer Street595 ANGLUM DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147318594
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRP
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameVIDAS
Generic NameIMMUNOFLUROMETER EQUIPMENT
Product CodeJZT
Date Received2001-05-08
Model NumberNA
Catalog NumberW2010
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key321140
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM DRIVE HAZELWOOD MO 63042 US
Baseline Brand NameVIDAS
Baseline Generic NameIMMUNOFLUOROMETER EQUIPMENT
Baseline Model NoNA
Baseline Catalog NoW2010
Baseline IDNA
Baseline Device FamilyVIDAS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK923579
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2001-05-08

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