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 2018-02-09 for DIMENSION VISTA? K1023 SMN 10445160 manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[99991332] Siemens healthcare diagnostics has confirmed that dimension vista? Calcium (ca) flex? Reagent cartridge lot 17171bd may produce erroneously low results from specific well sets. If ca reagent calibration is performed using an unaffected well set and qc and patient samples are subsequently processed using an affected well set, ca results may be falsely depressed up to -2. 8 mg/dl (-0. 7 mmol/l). If ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated. The observed bias for serum, plasma, and urine specimens are similar. Urgent medical device recall, vc-18-03. A. Us and urgent field safety notice vc-18-03. A. Ous dated january, 2018 were issued to customers who had been shipped dimension vista? Calcium (ca) flex? Reagent lot 17171bd. Customers were instructed to discontinue use and to discard lot 17171bd.
Patient Sequence No: 1, Text Type: N, H10


[99991333] Discordant falsely depressed calcium (ca) results were obtained on qc and patient samples on the dimension vista 500 instrument. The results were reported to the physician(s) and not questioned. The same samples were repeated after qc was noted to be out of range and higher results were obtained. Corrected reports were issued. There is no known report 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 Number2517506-2018-00058
MDR Report Key7260539
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-02-09
Date of Report2018-02-09
Date of Event2017-11-27
Date Mfgr Received2018-01-16
Device Manufacturer Date2017-06-20
Date Added to Maude2018-02-09
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
Remedial ActionRC
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 Received2018-02-09
Catalog NumberK1023 SMN 10445160
Lot Number17171BD
Device Expiration Date2018-06-20
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 2018-02-09

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