SIEMENS ADVIA CHEMISTRY 1800 ADVIA 1800 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-24 for SIEMENS ADVIA CHEMISTRY 1800 ADVIA 1800 * manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[3107781] Chemistry analyzer had malfunctioning pump which led to erroneously high glucose results being reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2892132
MDR Report Key2892132
Date Received2012-12-24
Date of Report2012-12-24
Date of Event2012-11-28
Report Date2012-12-24
Date Reported to FDA2012-12-24
Date Added to Maude2013-01-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSIEMENS ADVIA CHEMISTRY 1800
Generic NameANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) C
Product CodeJJG
Date Received2012-12-24
Model NumberADVIA 1800
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-24

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