DIMENSION EXL WITH LM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-18 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[5050298] A discordant, falsely elevated potassium (k) result was obtained on one patient sample on a dimension exl with lm instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument, resulting lower. It is unknown if the corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated k result.
Patient Sequence No: 1, Text Type: D, B5


[12561560] The customer contacted the siemens customer care center (ccc). The customer stated to ccc that controls were within range and no errors occurred at the time of event. The cause of the discordant, falsely elevated k result is unknown, as the sample resulted as expected upon repeat testing on the same instrument. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226181-2014-00589
MDR Report Key4259255
Report Source05,06
Date Received2014-11-18
Date of Report2014-10-24
Date of Event2014-10-24
Date Mfgr Received2014-10-24
Device Manufacturer Date2010-04-14
Date Added to Maude2014-11-28
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 FDA0
Event Location0
Manufacturer ContactCASSANDRA KOCSIS
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242687
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer Street101 SILVERMINE ROAD
Manufacturer CityBROOKFIELD CT 06804
Manufacturer CountryUS
Manufacturer Postal Code06804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION EXL WITH LM
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeMZV
Date Received2014-11-18
Model NumberDIMENSION EXL WITH LM
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer Address101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-18

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