DIMENSION VISTA 500 DIMENSION VISTA? 500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-09 for DIMENSION VISTA 500 DIMENSION VISTA? 500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[92638421] The customer contacted the siemens customer care center (ccc) to report the discordant glucose result. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse found that the service undermix method failed on sample 1 (s1) probe. The cse replaced s1 mixer and realigned probe. The cse ran mixer diagnostic and quick check, which passed. The cse checked s1 undermix, overmix, align and fluidics methods, which were acceptable. The cse re-calibrated glucose. The cse ran quality control and precision test on glucose sample, which were acceptable. The cause of the discordant glucose result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10


[92638422] A discordant, falsely low glucose result was obtained on one patient sample on a dimension vista 500 instrument. The initial result was not reported to the physician(s). The sample was repeated on the same instrument, resulting higher. The repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low glucose result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00810
MDR Report Key7014181
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-09
Date of Report2017-11-09
Date of Event2017-10-18
Date Mfgr Received2017-10-18
Device Manufacturer Date2013-08-26
Date Added to Maude2017-11-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARL AEBIG
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243102
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer Street101 SILVERMINE ROAD REGISTRATION # : 1226181
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 NameDIMENSION VISTA 500
Product CodeCFR
Date Received2017-11-09
Model NumberDIMENSION VISTA? 500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-09

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