DIMENSION VISTA 1500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-27 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[74156320] A siemens customer service engineer (cse) was dispatched to the customer's site. The cse checked the alignment of the aliquot probe, resulting within specifications. The cse noticed the sample cup with barcode was misplaced on the rack. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10


[74156321] Customer reported experiencing a three hour delay for c-reactive protein newborn patient sample on a dimension vista 1500 instrument. The initial result was not reported out to the physician(s) due to an instrument malfunction. The instrument malfunction caused a puncture in the sample cup. Due to the puncture, the patient was re-drawn and tested. The customer reported out the re-drawn sample result to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the three hour delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00464
MDR Report Key6528586
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-04-27
Date of Report2017-08-02
Date of Event2017-04-04
Date Mfgr Received2017-05-12
Device Manufacturer Date2009-05-29
Date Added to Maude2017-04-27
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 StreetREGISTRATION NUMBER: 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 CodeDCN
Date Received2017-04-27
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 NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-04-27
Model NumberDIMENSION VISTA 1500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2017-04-27

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