COBAS 8800 SYSTEM 05412722001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for COBAS 8800 SYSTEM 05412722001 manufactured by Roche Molecular Systems, Inc..

Event Text Entries

[134583921] The investigation is currently on-going. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[134583922] On (b)(6) 2019, during a visit to a (b)(6), roche personnel, including the local field service engineer, found the processing transfer heads, on the cobas 8800 system, failed the processing head tightness check, and there are observations of liquid waste droplets on the processing module deck, heating station, and separation station. No erroneous or invalid results were alleged to be generated, and no harm was indicated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243471-2019-00001
MDR Report Key8289950
Date Received2019-01-30
Date of Report2019-06-20
Date of Event2019-01-02
Date Mfgr Received2019-01-02
Date Added to Maude2019-01-30
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 8800 SYSTEM
Generic NameAUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT
Product CodeMZA
Date Received2019-01-30
Model NumberNA
Catalog Number05412722001
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
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 2019-01-30

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