I-STAT1 ANALYZER 600-0000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-03-27 for I-STAT1 ANALYZER 600-0000 manufactured by Abbott Point Of Care.

Event Text Entries

[103942808] 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


[103942809] On (b)(6) 2018, an abbott point of care distributor was contacted by a customer regarding an i-stat 1 analyzer that yielded suspected discrepant potassium result on a patient. There was no patient information available at the time of this report. (b)(6). 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 the limited 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 Number2245578-2018-00116
MDR Report Key7374749
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2018-03-27
Date of Report2018-06-04
Date of Event2018-03-09
Date Mfgr Received2018-05-31
Device Manufacturer Date2010-01-19
Date Added to Maude2018-03-27
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 G1FLEXTRONICS MANUFACTURING (SINGAPORE)
Manufacturer StreetPTE LTD 1 KALLANG PLACE
Manufacturer CitySINGAPORE 339211
Manufacturer CountrySN
Manufacturer Postal Code339211
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameI-STAT1 ANALYZER
Generic NameI-STAT1 ANALYZER
Product CodeMZV
Date Received2018-03-27
Model NumberNA
Catalog Number600-0000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
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-STAT1 ANALYZER
Generic NameI-STAT1 ANALYZER
Product CodeCGA
Date Received2018-03-27
Model NumberNA
Catalog Number600-0000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.