IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-03 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..

Event Text Entries

[17126530] A customer reported to beckman coulter, inc. (bec) that the immage 800 immunochemistry system leaked a clear and odorless fluid from the sample drain under the probe. The fluid dripped onto the floor. The customer was wearing gloves and eye protection when the leak was discovered. There was no report of injury or exposure, and medical attention was not sought. Msds was not reviewed, but the facility has an emergency chemical spill plan in place. No erroneous patient results were generated. Bec field service engineer (fse) observed a sample probe wash station overflow. The fse replaced both wash station waste filters and the cuvette wash station waste filter. Service activity performed was verified per established procedures, and the results met published performance specifications.
Patient Sequence No: 1, Text Type: D, B5


[17351711] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2012-01896
MDR Report Key2855139
Report Source05,06
Date Received2012-12-03
Date of Report2012-11-07
Date of Event2012-11-07
Date Mfgr Received2012-11-07
Device Manufacturer Date2010-01-29
Date Added to Maude2013-03-08
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 FDA0
Event Location0
Manufacturer ContactMS. DUNG NGUYEN
Manufacturer Street250 S. KRAEMER BLVD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149614941
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 NameNEPHELOMETER, FOR CLINICAL USE
Product CodeJQX
Date Received2012-12-03
Model NumberIMMAGE 800
Catalog NumberA15445
Lot NumberNA
ID NumberSOFTWARE V. 2.0.10
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 2012-12-03

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