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 2018-02-06 for DIMENSION VISTA? K1023 SMN 10445160 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[99787219] The customer contacted the siemens customer care center (ccc) stating that they had gotten a complaint from a physician in regards to a low calcium (ca) result. The result was low relative to the result obtained with an alternate non-siemens instrument system. The customer noted that quality control (qc) results for the date the sample was run were within acceptable ranges and no proficiency testing failures have occurred. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10


[99787220] A discordant falsely depressed calcium (ca) result was obtained on a patient sample on the dimension vista 500 instrument. The result was reported to the physician who questioned the result. The same sample was repeated on an alternate non-siemens instrument system and a higher result was obtained. No corrected report was issued. There is no known report of patient intervention or adverse health consequences due to the discordant falsely depressed ca result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2018-00076
MDR Report Key7244065
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-02-06
Date of Report2018-02-22
Date of Event2017-09-15
Date Mfgr Received2018-02-07
Device Manufacturer Date2017-07-26
Date Added to Maude2018-02-06
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 Street500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal Code197146101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION VISTA?
Generic NameDIMENSION VISTA? CA CALCIUM FLEX? REAGENT CARTRIDGE
Product CodeCIC
Date Received2018-02-06
Catalog NumberK1023 SMN 10445160
Lot Number17206BC
Device Expiration Date2018-07-25
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 2018-02-06

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