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HemoCue America, Glucose 201 DM Analyzer (BedsideGlucose_2018)

HemoCue America, Glucose 201 DM Analyzer (BedsideGlucose_2018)

Bedside glucose testing systems, April 2018

Contact Information

HemoCue America
Brea, California

Name of instrument/First year sold Glucose 201 DM Analyzer/2005
Professional or home use professional
Total units sold in U.S./Total units sold outside U.S.
No. of contracts for product signed in 2017
Dimensions (H × W × D)/Weight 6.7 × 3.7 × 2 in/0.77 lbs
Analytical method or technology or enzyme system used absorbance photometry, glucose dehydrogenase
No. of disposable reagent system units per basic package 25 in vial, 4 vials per package; 25 in box, 2 boxes per package
Disposable units shelf life/Reagent unit storage requirements 9 months from manufacture date/refrigeration
Digital readout character size/Keypad input capability varies from 8–28 points/menu selection, numeric, alphabetic
How results are displayed plasma equivalent values
Specimen types/Sampling techniques whole blood, venous, capillary, or arterial/exact amount of blood is drawn into the cuvette by capillary force
Minimum specimen volume required 5 µL
Suitable for samples from well neonates/Sick neonates yes/yes
Time from sample introduction to result availability 40–240 seconds
Batteries used/No. used/Average life of one set of batteries rechargeable lithium ion supplied by HemoCue/—/several years
Average expected life of device/Mean time between failures 7 years/>5 years
Device warranty/Service options/Loaners provided 3 years, at no extra cost/replacement of defective analyzer/yes
User list or user group no
Toll-free No. for customer questions/Hours of operation 800-323-1674/6 am–5 pm PST
Training and certification program/No. of training days provided yes/as needed
Average time for lab to complete maintenance daily: ≤5 minutes
Internal QC recommended or required as specified by accreditation
Between instrument CV (based on PT) at the following glucose levels:
• <50 mg/dL
• 100–200 mg/dL 3.8
• >400 mg/dL ≥272 mg/dL=2.9
• Program name, year/Challenge No./Level of mean glucose challenge sample Equalis (Swedish PT program), 2003/2003–03; 2003–07/272 mg/dL; 120 mg/dL
Accuracy/Compared with what reference method or device ±10% or ±6% mg/dL; corr=0.994/wet chemical glucose dehydrogenase, ­ID-GCMS
Precision/Compared with what reference method or device within run CV 1.9 % (108 mg/dL)/—
Linear range 0–444 mg/dL
Suggested dynamic or measurement range 0–444 mg/dL
Contraindications no
Known interferences/High-altitude interference grossly lipemic samples, methemoglobin, glucosamine/no
Restrictions based on hematocrit no
Electronic and optical function checks internal electronic self-test automatically checks the instrument’s optronic unit is working properly
Sample quantity checks visual inspection
When auto lock or shutdown occurs user ID failure if configured to require operator ID, QC failure if configured to require quality control, number of device errors
User defines QC lockout intervals/QC lockout can be circumvented yes/no (stat testing may be allowed; 1–100 tests after QC interval)
Information for which device supports barcode scanning operator ID, patient ID, reagent lot Nos., comments, log entries, lab ID
Method of analyst ID/ID required alphanumeric manual entry or barcode scan entry/optional
Internal memory size/Maximum No. of patient results stored 4,000 patient tests, 500 QC tests, 500 analyzer log entries/4,000
Meter connections for information transfer analyzer connects to 201 DM docking stations data-management system, which can further transmit data
How meters are connected to external system to upload results direct USB/hospital network
Information contained in transmission to external system device-unique identifiers, operator and patient IDs, results, QC identifiers, POCT-1A standard compliant, test dates and times, lab ID, flags
Hardware/software for data-management system PC, server/HemoCue 201 DM–DMS software
No. of different management reports system can produce 15 different templates, custom reports based on templates, multiple export formats
Contents downloaded from DMS to meter cuvette lot No., valid control values, valid operator IDs, comments, analyzer log entries, analyzer configuration
LISs/HISs to which system is connected (live installs) using:
• Screen animation/Screen scraping
• Standard HL7 interface Cerner, Orchard, Sunquest, EHS, SoftLab, M-Magic, Starlab, M-CS, HorizonLab
• Proprietary protocol interface
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces yes (MAS-RALS, LDS AegisPOC, Telcor, Sybase, RALS Web3, Radiometer Radiance)
LOINC can be used to identify tests when communicating with LIS
Distinguishing features (supplied by company) POCT-1A compliant; indicated for diagnosis of diabetes mellitus; not hematocrit dependent; CLIA waived; lab verification of patient home meter; no interference from maltose or galactose; no need to recalibrate
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.