COBAS 6800 SYSTEM 05524245001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-12 for COBAS 6800 SYSTEM 05524245001 manufactured by Roche Molecular Systems, Inc..

MAUDE Entry Details

Report Number2243471-2019-00028
MDR Report Key8784589
Date Received2019-07-12
Date of Report2019-07-12
Date of Event2019-06-24
Date Mfgr Received2019-06-24
Date Added to Maude2019-07-12
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 STACIE-ANN CREIGHTON
Manufacturer Street1080 US HWY 202 S NA
Manufacturer CityBRANCHBURG NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone9082537112
Manufacturer G1ROCHE INTERNATIONAL ROTKREUZ
Manufacturer StreetFORRENSTRASSE 2 NA
Manufacturer CityROTKREUZ 6343
Manufacturer CountryCH
Manufacturer Postal Code6343
Single Use3
Previous Use Code3
Removal Correction Number2243471-06-06-2019-001-C
Event Type3
Type of Report0

Device Details

Brand NameCOBAS 6800 SYSTEM
Generic NameAUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT
Product CodeMZA
Date Received2019-07-12
Model NumberNA
Catalog Number05524245001
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE MOLECULAR SYSTEMS, INC.
Manufacturer Address1080 US HIGHWAY 202 S NA BRANCHBURG NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-12

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