IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-13 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter Inc..

Event Text Entries

[1980871] A customer contacted beckman coulter inc. (bci) regarding intermittent cuvette overflow on the immage 800 immunochemistry system. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[9109032] A field service engineer (fse) went on-site (b)(4) 2011 and replaced the vacuum tubing which resolved the issue.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2011-01578
MDR Report Key2088232
Report Source06
Date Received2011-05-13
Date of Report2011-04-15
Date of Event2011-04-15
Date Mfgr Received2011-04-15
Device Manufacturer Date2004-11-02
Date Added to Maude2012-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. NORA ZEROUNIAN
Manufacturer Street250 S. KRAEMER BOULEVARD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149613634
Manufacturer G1BECKMAN COULTER INC.
Manufacturer Street250 S. KRAEMER BLVD.
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal Code92821
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameIMMAGE? 800 IMMUNOCHEMISTRY SYSTEM
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJQX
Date Received2011-05-13
Model NumberNA
Catalog NumberA15445
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2011-05-13

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