MYO2 TINA-QUANT MYOGLOBIN GEN.2 MYO G2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-20 for MYO2 TINA-QUANT MYOGLOBIN GEN.2 MYO G2 manufactured by Roche Diagnostics.

MAUDE Entry Details

Report Number1823260-2019-90216
MDR Report Key8909904
Date Received2019-08-20
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
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG), 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction Number1823260-06/28/2019-006-C
Event Type3
Type of Report0

Device Details

Brand NameMYO2 TINA-QUANT MYOGLOBIN GEN.2
Generic NameMYOGLOBIN IMMUNOLOGICAL TEST SYSTEM
Product CodeDDR
Date Received2019-08-20
Model NumberMYO G2
Lot Number349860, ASKU
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-20

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