DIMENSION EXL 200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-20 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[73228697] The customer contacted a siemens customer care center (ccc) specialist. The customer stated that quality controls and calibrations were within acceptable range. The customer repeated the sample in duplicate and the results were acceptable. The cause of the discordant, falsely low rcrp result on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10


[73228699] A discordant, falsely low revised c-reactive protein (rcrp) result was obtained on one patient sample on a dimension exl 200 instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated in duplicate on the same instrument and both replicates resulted higher. One of the replicates was reported as a correct result to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low rcrp result.
Patient Sequence No: 1, Text Type: D, B5


[86997435] The initial mdr 2517506-2017-00413 was filed on april 20, 2017. Additional information (04/07/2017): a siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and quality control charts and released the instrument for routine use with the exception of revised c-reactive protein (rcrp). A siemens headquarters support center specialist reviewed the information provided and could not determine the cause of the discordant, falsely low rcrp result.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2517506-2017-00413
MDR Report Key6506949
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-04-20
Date of Report2017-07-18
Date of Event2017-03-25
Date Mfgr Received2017-06-23
Device Manufacturer Date2014-12-30
Date Added to Maude2017-04-20
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 ContactKARL AEBIG
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243102
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 EXL 200
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeDCN
Date Received2017-04-20
Model NumberDIMENSION EXL 200
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 EXL 200
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-04-20
Model NumberDIMENSION EXL 200
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 2017-04-20

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