PICCOLO XPRESS CHEMISTRY ANALYZER 1100-0000

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 2020-01-02 for PICCOLO XPRESS CHEMISTRY ANALYZER 1100-0000 manufactured by Abaxis, Inc..

MAUDE Entry Details

Report Number2939693-2020-00003
MDR Report Key9541918
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-02
Date of Report2020-01-02
Date of Event2019-12-03
Date Mfgr Received2019-12-04
Device Manufacturer Date2017-05-16
Date Added to Maude2020-01-02
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 FDA3
Event Location3
Manufacturer ContactMS. RONI THEBO
Manufacturer Street3240 WHIPPLE RD
Manufacturer CityUNION CITY CA 94587
Manufacturer CountryUS
Manufacturer Postal94587
Manufacturer Phone2693599544
Manufacturer G1ABAXIS, INC.
Manufacturer Street3240 WHIPPLE ROAD
Manufacturer CityUNION CITY CA 94587
Manufacturer CountryUS
Manufacturer Postal Code94587
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2939693-12/16/2019-001-R
Event Type3
Type of Report3

Device Details

Brand NamePICCOLO XPRESS CHEMISTRY ANALYZER
Generic NamePICCOLO ANALYZER
Product CodeJJG
Date Received2020-01-02
Returned To Mfg2019-12-16
Model Number1100-0000
Catalog Number1100-0000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABAXIS, INC.
Manufacturer Address3240 WHIPPLE ROAD UNION CITY CA 94587 US 94587


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-02

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