DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM 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 2014-03-20 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[4258001] A discordant, falsely elevated potassium result was obtained on one patient sample on a dimension vista 1500 instrument. The sample was flagged and automatically repeated and resulted lower than the initial result, but the value was still elevated. The discordant result(s) was reported to the physician(s), who treated the patient. The sample was repeated on the same instrument and resulted lower than both of the previous results. There are no known reports of adverse health consequences due to the discordant, falsely elevated potassium results.
Patient Sequence No: 1, Text Type: D, B5


[11590814] A siemens global product support specialist evaluated, the instrument data and did not find an instrument malfunction. The cause of the discordant, falsely elevated potassium results is unknown. It was discovered that the customer centrifuges patient samples outside of the tube vendor specifications, which is a failure to follow instructions. The instrument is performing according to specifications. No further evaluation of this device is required. Medwatch # (b)(4) was filed by the customer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226181-2014-00153
MDR Report Key3691330
Report Source05,06
Date Received2014-03-20
Date of Report2014-03-04
Date of Event2014-01-12
Date Mfgr Received2014-03-04
Device Manufacturer Date2011-06-13
Date Added to Maude2014-05-20
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 CLINICAL CHEMISTRY SYSTEM
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeMZV
Date Received2014-03-20
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 RD BROOKFIELD CT 06804 US 06804


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-20

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