SYNCHRON? CX3 DELTA CLINICAL SYSTEM 467501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-05 for SYNCHRON? CX3 DELTA CLINICAL SYSTEM 467501 manufactured by Beckman Coulter Inc..

Event Text Entries

[1784068] A customer contacted beckman coulter inc. (bci) stating that the creatinine (c) module was leaking and failing calibration. No injury was reported for this event.
Patient Sequence No: 1, Text Type: D, B5


[8940841] The bci hotline had the customer reboot the instrument and the problem has not reoccurred.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2011-00055
MDR Report Key1949907
Report Source05
Date Received2011-01-05
Date of Report2010-12-07
Date of Event2010-12-07
Date Mfgr Received2010-12-07
Device Manufacturer Date2003-07-18
Date Added to Maude2012-01-20
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 BLVD
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 NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameSYNCHRON? CX3 DELTA CLINICAL SYSTEM
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJF
Date Received2011-01-05
Model NumberCX3 DELTA
Catalog Number467501
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address250 S KRAEMER BOULEVARD BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2011-01-05

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