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Siemens Dimension Exl 200 User Manual

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SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZERBack to Search Results
Model Number DIMENSION EXL 200
Event Date 10/07/2013
Event Type Malfunction
Event Description

A discordant, falsely low human chorionic gonadotropin (hcg) result was obtained on one patient sample on a dimension exl 200 instrument. The discordant result was flagged with a high 'a' error by the instrument and erroneously reported to the physician(s). The patient was given a computed tomography scan due to the falsely low result. The sample was repeated on the same instrument twice with manual dilution after being reported, and the instrument flagged both results. The sample was repeated on the same instrument after instrument re-configuration, and the sample resulted higher. It is unknown if the correct result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low hcg result.

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Manufacturer Narrative

The customer contacted the siemens technical solutions center (tsc). The customer stated to tsc that the discordant result was flagged with a high 'a' error, and was not repeated before releasing the result to the physician(s). The operator did not follow the instructions in the operator guide for high 'a' errors, which mean that the sample requires dilution. Tsc instructed the customer to re-configure the instrument to allow performing auto-dilution on above assay range samples. The customer repeated the sample after troubleshooting, and the result was as expected. It was also discovered that the customer was centrifuging patient samples outside of the tube manufacturer specifications. The cause of the discordant, falsely low hcg result being reported is a user error. The cause of the samples being centrifuged outside of tube vendor specifications is failure to follow instructions. The instrument is performing according to specifications. No further evaluation of the device is required.

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Siemens Dimension Exl 200

Type of DeviceCLINICAL CHEMISTRY ANALYZER
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC
101 silvermine road
brookfield CT 06804
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS INC
101 silvermine road
brookfield CT 06804
Manufacturer Contact
cassandra kocsis
511 benedict avenue
tarrytown , NY 10591
9145242687
MDR Report Key3444283
Report Number1226181-2013-00476
Device Sequence Number1
Product CodeDHA
Report Source Manufacturer
Source TypeHealth Professional,User facility
Reporter Occupation HEALTH PROFESSIONAL
Type of ReportInitial
Report Date10/07/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDIMENSION EXL 200
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/07/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/04/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Siemens Dimension Exl 200 Manual

The Dimension® EXL™ 200 Integrated Chemistry System with patented LOCI® Advanced Chemiluminescent Technology and automated productivity-enhancing features for both the low-volume laboratory and the STAT laboratory.
Trusted, proven technologies, including LOCI chemiluminescence, for fast and reliable results
Easy-to-use Dimension system provides the confidence that trained operators can run any test, any time
Chemistry and immunoassay integration allows simultaneous processing to maximize workflow efficiency
LOCI technology inside
Trusted results in a flash
Homogeneous chemiluminescent technology
Fast and accurate
Excellent precision
High sensitivity
Short reaction times, no washing or separation steps
Excellent STAT testing capability
Low sample volume required
True integration
Integration of chemistry and immunoassay with a comprehensive menu
One sample area
Common reagent area
Common reagent packaging
Trusted, proven technologies
LOCI® advanced chemiluminescence
Heterogeneous Module
Photometry
QuikLYTE® IMT
User-defined serum index (HIL) testing
Automation capabilities
Workflow efficiency
Process any test, any time, any shift
Plasma qualified assays
Fully automated onboard pretreatment (when required)
Fewer manual tasks
Automated calibration and control procedures
Infrequent calibration
Paperless, electronic data storage
Proactive STAT, sample, supply, QC and calibration alerts
No manual reagent preparation
No manual sample pretreatment
No limit or dedicated STAT positions required