SYNCHRON SYSTEMS LIPID CALIBRATOR 650218

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-26 for SYNCHRON SYSTEMS LIPID CALIBRATOR 650218 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2728447] The beckman coulter (bec) receiving warehouse reported that the lipid calibrator cartridge was leaking due to damage to the cartridge. The proper ppe (personal protective equipment) was used when handling the product. No one came in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed.
Patient Sequence No: 1, Text Type: D, B5


[10059396] The damaged reagent cartridge was in the control and custody of the bec warehouse. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2012-01316
MDR Report Key2628399
Report Source01,07
Date Received2012-06-26
Date of Report2012-05-29
Date of Event2012-05-29
Date Mfgr Received2012-05-29
Device Manufacturer Date2011-08-09
Date Added to Maude2012-10-16
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 928216232
Manufacturer CountryUS
Manufacturer Postal928216232
Manufacturer Phone7149614941
Manufacturer G1BECKMAN COULTER, INC.
Manufacturer Street250 S. KRAEMER BLVD.
Manufacturer CityBREA CA 92821623
Manufacturer CountryUS
Manufacturer Postal Code92821 6232
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNCHRON SYSTEMS LIPID CALIBRATOR
Generic NameCALIBRATOR, PRIMARY
Product CodeJIS
Date Received2012-06-26
Model NumberNA
Catalog Number650218
Lot NumberM103070
Device Expiration Date2012-10-31
OperatorOTHER
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232


Patients

Patient NumberTreatmentOutcomeDate
10 2012-06-26

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