GENTAMICIN REAGENT TEST KIT GEN REAGENT 469137

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 2012-04-03 for GENTAMICIN REAGENT TEST KIT GEN REAGENT 469137 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2576474] Customer called to report that approximately 20 milliliters of one gentamicin reagent cartridge, lot # m111207, was found leaking upon receipt of the ashes. Damage was found only to the internal kit, but not to the shipping box. The cause of the leak could not be determined. Customer was asked to empty the contents of the cartridge and to store the cartridge using proper laboratory procedures in the case that an investigation of the cartridge damage was necessary. Customer was wearing personal protective equipment (ppe) consisting of a laboratory coat and gloves. Customer did not come 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. There was no death, injury or change to patient treatment attributed to or associated with this complaint. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5


[9708260] Customer was offered a new reagent kit, but declined the offer. The other cartridge contained in the shipment was not damaged. Customer has not called back to report any further issues or harm by exposure as a result of the leak. (note: the beckman coulter, inc. Identifier for this report is (b)(4). Shipment damage determined via telephone
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2012-00842
MDR Report Key2515585
Report Source05,06
Date Received2012-04-03
Date of Report2012-03-15
Date of Event2012-03-15
Date Mfgr Received2012-03-15
Device Manufacturer Date2012-03-06
Date Added to Maude2012-09-06
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 NameGENTAMICIN REAGENT TEST KIT
Generic NameENZYME IMMUNOASSAY, GENTAMICIN
Product CodeLCD
Date Received2012-04-03
Model NumberGEN REAGENT
Catalog Number469137
Lot NumberM111207
Device Expiration Date2014-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232


Patients

Patient NumberTreatmentOutcomeDate
10 2012-04-03

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