COBAS INFINITY CORE SOFTWARE 07154003001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-11-13 for COBAS INFINITY CORE SOFTWARE 07154003001 manufactured by Roche Diagnostics.

MAUDE Entry Details

Report Number1823260-2019-04060
MDR Report Key9315043
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-11-13
Date of Report2019-11-13
Date of Event2019-10-21
Date Mfgr Received2019-10-28
Date Added to Maude2019-11-13
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 ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCOBAS INFINITY CORE SOFTWARE
Generic NameCALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
Product CodeJQP
Date Received2019-11-13
Model NumberNA
Catalog Number07154003001
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-13

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