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

[16267498] Customer called mfr's support department to report false negative rubella test results on the vidas instrument when the assay was run in one of the instrument's 30 positions, specifically section b, channel 5. Field service was dispatched and replaced the pump in that position. Further analysis of the pump indicates that the tubes within the pump were clogged.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2001-00005
MDR Report Key331767
Report Source01
Date Received2001-05-08
Date of Report2001-05-08
Date of Event2001-02-28
Date Mfgr Received2001-02-28
Device Manufacturer Date1992-02-01
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 Key321136
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.