DIMENSION VISTA 1500

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 2017-10-09 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[89955661] The customer contacted a siemens customer care center (ccc) and stated that their quality controls were within specification. The ccc specialist dialed into the system remotely and determined that there was a process error for the aliquot probe and the container bottom was not found. The ccc specialist ran a quick check, which passed. The aliquot probe was replaced and aligned. The ccc specialist stated that the issue was resolved by replacing the aliquot probe. The instrument is performing within manufacturing specifications. No further evaluation if device is required.
Patient Sequence No: 1, Text Type: N, H10


[89955662] A discordant, falsely low vancomycin result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the pharmacist, who questioned it. The sample was repeated on an alternate dimension vista instrument and on the original instrument, resulting higher both times. The corrected result from the alternate dimension vista instrument was reported. There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low vancomycin result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00759
MDR Report Key6929608
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-10-09
Date of Report2017-10-09
Date of Event2017-09-13
Date Mfgr Received2017-09-14
Device Manufacturer Date2017-04-03
Date Added to Maude2017-10-09
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 ContactKARL AEBIG
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243102
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer StreetREGISTRATION #: 1226181 101 SILVERMINE ROAD
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 VISTA 1500
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeLEH
Date Received2017-10-09
Model NumberDIMENSION VISTA 1500
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 VISTA 1500
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-10-09
Model NumberDIMENSION VISTA 1500
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 2017-10-09

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