ELECSYS 2010 LABORATORY ANALYZER 2010 RACK & DISK 1804014,1568248

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-18 for ELECSYS 2010 LABORATORY ANALYZER 2010 RACK & DISK 1804014,1568248 manufactured by Roche Diagnostics.

MAUDE Entry Details

Report Number1823260-1999-00002
MDR Report Key207163
Report Source05
Date Received1999-01-18
Date of Report1999-01-15
Date of Event1998-12-12
Date Mfgr Received1999-01-15
Date Added to Maude1999-01-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameELECSYS 2010 LABORATORY ANALYZER
Generic NameLABORATORY IMMUNOASSAY ANALYZER
Product CodeLCI
Date Received1999-01-18
Model Number2010 RACK & DISK
Catalog Number1804014,1568248
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key201079
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE RD. INDIANAPOLIS IN 46250 US
Baseline Brand NameELECSYS 2010 LABORATORY ANALYZER
Baseline Generic NameLABORATORY IMMUNOASSAY ANALYZER
Baseline Model No2010 RACK & DIS
Baseline Catalog No1804014,1568248
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 1999-01-18

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