DIMENSION VISTA? K1023 SMN 10445160

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 2017-11-01 for DIMENSION VISTA? K1023 SMN 10445160 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.

Event Text Entries

[91333719] The customer contacted the siemens healthcare diagnostics customer care center about the discordant falsely depressed ca results. The cause of the discordant falsely depressed ca results is unknown. The incident is under investigation by the siemens headquarters support center (hsc).
Patient Sequence No: 1, Text Type: N, H10


[91333720] Discordant falsely depressed calcium (ca) results were obtained on patient samples on the dimension vista 1500 instrument. The results were reported to the physician(s) who did not question the results. The same samples were repeated on the same instrument with an alternate ca flex reagent cartridge. Higher results were obtained. Corrected reports were issued. There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed ca results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00765
MDR Report Key6992761
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-01
Date of Report2018-02-09
Date of Event2017-10-07
Date Mfgr Received2018-01-16
Device Manufacturer Date2017-06-20
Date Added to Maude2017-11-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAMES MORGERA
Manufacturer StreetGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer StreetGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal Code197146101
Single Use3
Previous Use Code3
Removal Correction Number2517506-02/01/2018-001-R
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION VISTA?
Generic NameDIMENSION VISTA? CA CALCIUM FLEX? REAGENT CARTRIDGE
Product CodeCIC
Date Received2017-11-01
Catalog NumberK1023 SMN 10445160
Lot Number17171BD
Device Expiration Date2018-06-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Manufacturer AddressGLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-01

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