IMMAGE IMMUNOCHEMISTRY SYSTEM N/A 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 2012-08-15 for IMMAGE IMMUNOCHEMISTRY SYSTEM N/A A15445 manufactured by Beckman Coulter, Inc..

Event Text Entries

[19998868] On (b)(6) 2012, customer reported that wash solution overflowed from the sample wash station on the immage 800 instrument. The volume of the leak was unknown. No injuries were reported and no erroneous patient results were generated. Field service engineer (fse) inspected the instrument and replaced an occluded wash station filter. This resolved the issue and no further leaks were reported.
Patient Sequence No: 1, Text Type: D, B5


[20275885] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2012-01681
MDR Report Key2700172
Report Source05,06
Date Received2012-08-15
Date of Report2012-07-25
Date of Event2012-07-25
Date Mfgr Received2012-07-25
Device Manufacturer Date2004-05-14
Date Added to Maude2012-12-03
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 SOUTH KRAEMER BOULEVARD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149614941
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMAGE IMMUNOCHEMISTRY SYSTEM
Generic NameNEPHELOMETER, FOR CLINICAL USE
Product CodeJQX
Date Received2012-08-15
Model NumberN/A
Catalog NumberA15445
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-15

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