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 2017-11-08 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[92605102] The customer contacted the siemens customer care center (ccc) to report the discordant vancomycin result. Siemens is investigating issue. Mdr 2517506-2017-00805 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10


[92605103] A discordant, vancomycin result was obtained on one patient sample on a dimension vista 1500 (serial number (b)(4)) instrument. The sample was also run on an alternate dimension vista instrument (serial number (b)(4)), resulting falsely low. The discordant result was not reported to the physician(s). The sample was repeated on the same (serial number (b)(4)) and on an alternate (serial number (b)(4)) instrument, resulting higher. The correct result obtained on the same (serial number (b)(4)) instrument, after re-centrifugation, was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant vancomycin result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00806
MDR Report Key7011581
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-08
Date of Report2017-12-07
Date of Event2017-10-11
Date Mfgr Received2017-11-13
Device Manufacturer Date2010-05-27
Date Added to Maude2017-11-08
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 AVE
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 VISTA 1500
Generic NameDIMENSION VISTA 1500
Product CodeLEH
Date Received2017-11-08
Model NumberDIMENSION VISTA 1500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 NameDIMENSION VISTA 1500
Product CodeJJE
Date Received2017-11-08
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 2017-11-08

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