COBAS P 512 PRE-ANALYTICAL SYSTEM P512 07563124001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-20 for COBAS P 512 PRE-ANALYTICAL SYSTEM P512 07563124001 manufactured by Roche Diagnostics.

MAUDE Entry Details

Report Number1823260-2019-03041
MDR Report Key8910417
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-08-20
Date of Report2019-08-20
Date of Event2019-07-23
Date Mfgr Received2019-07-23
Date Added to Maude2019-08-20
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 P 512 PRE-ANALYTICAL SYSTEM
Generic NameAUTOMATED PREANALYTICAL SYSTEM
Product CodeJQP
Date Received2019-08-20
Model NumberP512
Catalog Number07563124001
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
101. Required No Informationntervention 2019-08-20

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