DIMENSION VISTA1500

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 2017-08-17 for DIMENSION VISTA1500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[83230107] The customer contacted the siemens technical support center (tsc) to report the discordant carbon dioxide (co2) results. The tsc ran service methods and found sample arm 3 (s3) and reagent arm 5 (r5) mixer faulty. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse replaced metering pump for s3, s3 and r5 mixer. The cse ran service methods and all were within specifications. The cse ran quality control (qc), which was in range. The cause of the discordant carbon dioxide results 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


[83230108] Discordant, falsely low carbon dioxide (co2) results were obtained on patient samples on a dimension vista 1500 instrument. The discordant results were not reported to the physician(s). The same samples were repeated on the same instrument, and recovered higher. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant co2 results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00661
MDR Report Key6802421
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-08-17
Date of Report2017-08-17
Date of Event2017-07-26
Date Mfgr Received2017-07-26
Device Manufacturer Date2015-11-19
Date Added to Maude2017-08-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMARGARITA KARAN
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243105
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street101 SILVERMINE ROAD REGISTRATION NUMBER: 1226181
Manufacturer CityBROOKFIELD CT 06804
Manufacturer CountryUS
Manufacturer Postal Code06804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameDIMENSION VISTA1500
Generic NameDIMENSION VISTA1500
Product CodeCHS
Date Received2017-08-17
Model NumberDIMENSION VISTA1500
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

Device Sequence Number: 1

Brand NameDIMENSION VISTA1500
Generic NameDIMENSION VISTA1500
Product CodeJJE
Date Received2017-08-17
Model NumberDIMENSION VISTA1500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-17

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