ELECSYS TSH ASSAY 11731459122

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for ELECSYS TSH ASSAY 11731459122 manufactured by Roche Diagnostics.

MAUDE Entry Details

Report Number1823260-2020-90037
MDR Report Key9641133
Date Received2020-01-29
Date Added to Maude2020-01-29
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
Event Type3
Type of Report3

Device Details

Brand NameELECSYS TSH ASSAY
Generic NameRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Product CodeJLW
Date Received2020-01-29
Model NumberTSH
Catalog Number11731459122
Lot Number402248, 41831803,
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 2020-01-29

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