I-STAT CG8+ CARTRIDGE 03P88-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-18 for I-STAT CG8+ CARTRIDGE 03P88-25 manufactured by Abbott Point Of Care.

MAUDE Entry Details

Report Number2245578-2020-00042
MDR Report Key9850218
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-18
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-11-15
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLINDA MACZUSZENKO
Manufacturer Street400 COLLEGE ROAD
Manufacturer CityPRINCETON, NJ
Manufacturer CountryUS
Manufacturer Phone6885949228
Manufacturer G1ABBOTT POINT OF CARE CANADA LTD.
Manufacturer Street185 CORKSTOWN ROAD
Manufacturer CityK2H 8V4
Manufacturer CountryCA
Manufacturer Postal CodeK2H 8V4
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameI-STAT CG8+ CARTRIDGE
Generic NameCG8+ CARTRIDGE
Product CodeCHL
Date Received2020-03-18
Model NumberNA
Catalog Number03P88-25
Lot NumberW19319
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON, NJ US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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