CARDIOCHEK PLUS ANALYZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for CARDIOCHEK PLUS ANALYZER manufactured by Pts Diagnostics.

MAUDE Entry Details

Report Number1836135-2019-00056
MDR Report Key9103994
Date Received2019-09-23
Date of Report2019-09-23
Date Mfgr Received2019-09-06
Date Added to Maude2019-09-23
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 ContactMR. BRANDON UNRUH
Manufacturer Street7736 ZIONSVILLE ROAD
Manufacturer CityINDIANAPOLIS IN 46278
Manufacturer CountryUS
Manufacturer Postal46278
Manufacturer Phone3178705610
Manufacturer G1PTS DIAGNOSTICS
Manufacturer Street7736 ZIONSVILLE ROAD
Manufacturer CityINDIANAPOLIS IN 46278
Manufacturer CountryUS
Manufacturer Postal Code46278
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCARDIOCHEK PLUS ANALYZER
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeCGA
Date Received2019-09-23
Returned To Mfg2019-09-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPTS DIAGNOSTICS
Manufacturer Address7736 ZIONSVILLE ROAD INDIANAPOLIS IN 46278 US 46278


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-23

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