DIMENSION VISTA 1500

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 2014-06-05 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[4411266] A discordant, falsely low potassium (k) result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument, resulting higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low k result.
Patient Sequence No: 1, Text Type: D, B5


[12112598] The customer contacted the siemens technical solutions center (tsc). A siemens headquarter support center (hsc) specialist evaluated the instrument data, which indicated hemolysis interference on the potassium result. Other tests ordered for the patient were not run due to a sample probe clog detected error. Hsc concluded that the cause of the discordant, falsely low k result is due to a sample integrity issue. 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 Number1226181-2014-00304
MDR Report Key3851539
Report Source05,06
Date Received2014-06-05
Date of Report2014-05-13
Date of Event2014-05-11
Date Mfgr Received2014-05-13
Device Manufacturer Date2009-12-04
Date Added to Maude2014-07-07
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 AVE
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 1500
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeMZV
Date Received2014-06-05
Model NumberDIMENSION VISTA 1500
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 2014-06-05

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