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 2013-12-19 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[3998356] A discordant, falsely elevated potassium (k) result was obtained on one patient sample on a dimension vista 500 instrument. The initial discordant result was reported to the physician(s), who questioned it. The patient was admitted from the er to the hospital and redrawn. Two redraw samples were obtained from the patient, both resulting as expected. The original sample was repeated on an alternate instrument, resulting as expected. It is unknown if 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 elevated k result.
Patient Sequence No: 1, Text Type: D, B5


[11308204] The customer contacted the siemens technical solutions center (tsc). The customer stated to the tsc that the original sample tube was received unspun. A global product support (gps) specialist evaluated the instrument data and did not find an instrument malfunction. It was discovered that the customer was centrifuging patient samples outside of the tube manufacturer specifications. The cause of the discordant, falsely elevated k result is unknown. The cause of the sample being centrifuged outside of tube vendor specifications is failure to follow instructions. 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 Number1226181-2013-00559
MDR Report Key3529059
Report Source05,06
Date Received2013-12-19
Date of Report2013-11-29
Date of Event2013-11-26
Date Mfgr Received2013-11-29
Device Manufacturer Date2009-12-28
Date Added to Maude2014-03-31
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 500
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeMZV
Date Received2013-12-19
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 2013-12-19

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