SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT 442785

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-12-19 for SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT 442785 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2499706] On (b)(6), 2011 customer reported that they received a cartridge of uric acid that was leaking from the base. No injuries or exposure were reported. Beckman coulter sent a replacement.
Patient Sequence No: 1, Text Type: D, B5


[9576882] Beckman coulter identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2011-08480
MDR Report Key2381373
Report Source01,05,06
Date Received2011-12-19
Date of Report2011-11-22
Date of Event2011-11-22
Date Mfgr Received2011-11-22
Device Manufacturer Date2011-08-03
Date Added to Maude2012-07-25
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 NameSYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
Generic NameACID, URIC, URICASE (COLORIMETRIC)
Product CodeKNK
Date Received2011-12-19
Catalog Number442785
Lot NumberM106422
Device Expiration Date2013-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2011-12-19

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