SYNCHRON CX TOTAL PROTEIN REAGENT 442740

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 2010-12-10 for SYNCHRON CX TOTAL PROTEIN REAGENT 442740 manufactured by Beckman Coulter Inc..

Event Text Entries

[1678551] A customer contacted beckman coulter inc. (bci) stating that cx total protein (tp) reagent bottles were received broken and leaking. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[8906101] The customer was sent replacement.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2010-01642
MDR Report Key1918974
Report Source06
Date Received2010-12-10
Date of Report2010-11-22
Date of Event2010-11-18
Date Mfgr Received2010-11-22
Device Manufacturer Date2010-07-06
Date Added to Maude2012-01-18
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
Remedial ActionRL
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSYNCHRON CX TOTAL PROTEIN REAGENT
Generic NameTOTAL PROTEIN REAGENT
Product CodeCEK
Date Received2010-12-10
Model NumberNA
Catalog Number442740
Lot NumberZ007007
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2010-12-10

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