VIDAS VIDAS 30 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 2001-09-13 for VIDAS VIDAS 30 W2010 manufactured by Biomerieux, Inc..

Event Text Entries

[216735] Customer called european office to complain of incorrect results using co's rbg assay. Field svc was dispatched and after testing the pump replaced the pump. Further analysis by engineering staff revealed that the pump was clogged.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2001-00015
MDR Report Key351836
Report Source01
Date Received2001-09-13
Date of Report2001-09-13
Date of Event2001-08-28
Date Mfgr Received2001-08-28
Device Manufacturer Date1992-04-01
Date Added to Maude2001-09-19
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 Phone6363918289
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameVIDAS
Generic NameIMMUNOFLUROMETRIC EQUIPMENT
Product CodeJZT
Date Received2001-09-13
Model NumberVIDAS 30
Catalog NumberW2010
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key341117
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM DR. HAZELWOOD MO 63042 US
Baseline Brand NameVIDAS
Baseline Generic NameIMMUNOFLUOROMETER EQUIPMENT
Baseline Model NoVIDAS 30
Baseline Catalog NoW2010
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2001-09-13

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