DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-29 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[3901301] A discordant, falsely elevated potassium result was obtained on one patient sample on a dimension vista 500 instrument. It is unknown if the discordant result was reported to the physician(s). The patient was redrawn and the new sample was run on the same instrument and resulted lower. The original sample from the patient was then rerun twice on the same instrument and resulted lower. It is unknown if the rerun results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated potassium result.
Patient Sequence No: 1, Text Type: D, B5


[11451666] A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse did not find an instrument malfunction. System checks were acceptable and quality controls were within range. The sample had resulted as expected upon repeat testing on the same instrument. The cause of the discordant, falsely elevated potassium result on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226181-2013-00469
MDR Report Key3435983
Report Source05,06
Date Received2013-10-29
Date of Report2013-10-02
Date of Event2013-09-26
Date Mfgr Received2013-10-02
Device Manufacturer Date2010-11-04
Date Added to Maude2014-01-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCASSANDRA KOCSIS
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242687
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street101 SILVERMINE ROAD
Manufacturer CityBROOKFIELD CT 06804
Manufacturer CountryUS
Manufacturer Postal Code06804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION VISTA CLINICAL CHEMISTRY SYSTEM
Generic NameCLINICAL CHEMISTRY SYSTEM
Product CodeMZV
Date Received2013-10-29
Model NumberDIMENSION VISTA 500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804


Patients

Patient NumberTreatmentOutcomeDate
10 2013-10-29

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