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 2017-03-08 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[69369584] The customer contacted the siemens customer care center (ccc). The customer indicated that after replacing the q-gard, quality controls for levels 1 and 3 were within ranges and precision study for the sample in question, were satisfactory for all tests. Ccc instructed the customer to replace sample 1 probe as the sample probe counter exhibited elevated cycle counts reading. A siemens headquarter support center (hsc) specialist reviewed the data which indicated that qc results were within acceptable range, denoting proper method performance. The cause of the discordant, falsely elevated phos result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


[69369585] A discordant, falsely elevated phosphorus (phos) result was obtained on a patient sample on a dimension vista 500 instrument. The discordant result was reported to the physician(s) who questioned it. The sample was repeated on the same dimension vista instrument, resulting lower. 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 elevated phos result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00189
MDR Report Key6387088
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-03-08
Date of Report2017-03-08
Date of Event2017-02-10
Date Mfgr Received2017-02-10
Device Manufacturer Date2012-10-31
Date Added to Maude2017-03-08
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 ContactMS. CASSANDRA KOCSIS
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242687
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 500
Generic NameCLINICAL CHEMISTRY ANALYZER,
Product CodeCEO
Date Received2017-03-08
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

Device Sequence Number: 1

Brand NameDIMENSION VISTA 500
Generic NameCLINICAL CHEMISTRY ANALYZER,
Product CodeJJE
Date Received2017-03-08
Model NumberDIMENSION VISTA 500
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 2017-03-08

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