I-STAT EG6+ CARTRIDGE 03P77-25

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 2018-03-05 for I-STAT EG6+ CARTRIDGE 03P77-25 manufactured by Abbott Point Of Care.

Event Text Entries

[101844593] Apoc incident # (b)(4). Apoc labeling will be evaluated during the investigation as pertaining to the event.
Patient Sequence No: 1, Text Type: N, H10


[101844594] On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer regarding i-stat eg6+ cartridges that yielded a suspected discrepant hemoglobin result on a (b)(6) year old male patient with cerebral infarction and renal failure. The patient is in the terminal stage. Blood transfusions are conducted once every two weeks. There was no additional patient information at the time of this report. Return product is available for investigation. (b)(6). Collection and test times were not available. There are no injuries associated with this event. At this time there is no reason to suspect a malfunction exists. The reporting decision was based on information available that suggests the product was not performing within the variability of the assay. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2245578-2018-00098
MDR Report Key7314511
Report SourceHEALTH PROFESSIONAL
Date Received2018-03-05
Date of Report2018-04-20
Date of Event2018-02-19
Date Mfgr Received2018-04-18
Device Manufacturer Date2017-09-30
Date Added to Maude2018-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 08540
Manufacturer CountryUS
Manufacturer Postal08540
Manufacturer Phone6136885949
Manufacturer G1ABBOTT POINT OF CARE CANADA LTD.
Manufacturer Street185 CORKSTOWN ROAD
Manufacturer CityOTTAWA, ONTARIO K2H 8V4
Manufacturer CountryCA
Manufacturer Postal CodeK2H 8V4
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameI-STAT EG6+ CARTRIDGE
Generic NameEG6+ CARTRIDGE
Product CodeGKR
Date Received2018-03-05
Model NumberNA
Catalog Number03P77-25
Lot NumberW17273
Device Expiration Date2018-05-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607

Device Sequence Number: 1

Brand NameI-STAT EG6+ CARTRIDGE
Generic NameEG6+ CARTRIDGE
Product CodeCHL
Date Received2018-03-05
Returned To Mfg2018-03-26
Model NumberNA
Catalog Number03P77-25
Lot NumberW17273
Device Expiration Date2018-05-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-05

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