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Roche Diagnostics, Accu-Chek Inform II System (BedsideGlucose_2018)

Bedside glucose testing systems, April 2018

Contact Information

Roche Diagnostics
Accu-Chek Customer Care Service Center
Indianapolis, IN

Name of instrument/First year sold Accu-Chek Inform II System/2012
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 1.85 × 3.62 × 7.48 in/12.35 oz (350 g)
Analytical method or technology or enzyme system used electrochemical (AC/DC), mutant variant quinoprotein glucose dehydrogenase
No. of disposable reagent system units per basic package 50 strips per vial
Disposable units shelf life/Reagent unit storage requirements 18 months/39°–86°F (4°–30°C)
Digital readout character size/Keypad input capability test results are 48-point font/menu selection, numeric, alphabetic
How results are displayed plasma equivalent values
Specimen types/Sampling techniques fresh capillary, venous, arterial, neonate whole blood/drop
Minimum specimen volume required 0.6 µL
Suitable for samples from well neonates/Sick neonates yes/yes
Time from sample introduction to result availability 5 seconds
Batteries used/No. used/Average life of one set of batteries 3.7v Li-polymer (rechargeable)/1/5 years
Average expected life of device/Mean time between failures 5 years/—
Device warranty/Service options/Loaners provided 1 year or for term of contract/replacement/no
User list or user group yes
Toll-free No. for customer questions/Hours of operation 800-440-3638/24 hours, 7 days, all year
Training and certification program/No. of training days provided yes/defined during implementation planning
Average time for lab to complete maintenance none beyond cleaning and disinfection
Internal QC recommended or required follow facility policy for control testing intervals
Between instrument CV (based on PT) at the following glucose levels:
• <50 mg/dL
• 100–200 mg/dL
• >400 mg/dL
• Program name, year/Challenge No./Level of mean glucose challenge sample
Accuracy/Compared with what reference method or device capillary: r=0.993, venous: r=0.995, arterial: r=0.990, neonatal: r=0.976/hexokinase method traceable to NIST
Precision/Compared with what reference method or device controls: low SD=1.2 mg/dL, mid SD=2.2, high SD=4.6, low CV=2.6%, mid CV=1.9%, high CV=1.5%; blood: 1 SD=1.2 mg/dL, 3 SD=4.2 mg/dL, 5 SD=9.5 mg/dL, 1 CV=3.3%, 3 CV=3.4%, 5 CV=3.0%/hexokinase method traceable to NIST
Linear range 10–600 mg/dL
Suggested dynamic or measurement range 10–600 mg/dL
Contraindications yes, per labeling
Known interferences/High-altitude interference per labeling/none, up to 10,000 feet
Restrictions based on hematocrit yes, 10–65%
Electronic and optical function checks 150 integrity checks, including variation in hematocrit, temperature, and humidity
Sample quantity checks sampling checked electronically for complete sample dosing
When auto lock or shutdown occurs user ID failure, QC failure, download interval lockout
User defines QC lockout intervals/QC lockout can be circumvented yes/no
Information for which device supports barcode scanning operator ID, patient ID, reagent lot, QC lot
Method of analyst ID/ID required alphanumeric or barcode scan/required
Internal memory size/Maximum No. of patient results stored 1,000 results, 5,000 operator IDs, 4,000 patient IDs, 300 predefined comments/—
Meter connections for information transfer data-management system, which connects to LIS-HIS
How meters are connected to external system to upload results direct serial, hospital network, real-time wireless (RF)
Information contained in transmission to external system device unique identifier, operator ID, patient ID, result, QC identifier, strip lot numbers, proficiency and linearity samples, comments
Hardware/software for data-management system Cobas IT 1000 application for connection to third-party DMS, including Telcor QML, Alere RALS
No. of different management reports system can produce varies by data manager (customer defined)
Contents downloaded from DMS to meter strip lot numbers, valid control values, valid operator IDs, patient IDs, meter configuration, linearity lot numbers and values, comments
LISs/HISs to which system is connected (live installs) using:
• Screen animation/Screen scraping
• Standard HL7 interface yes
• Proprietary protocol interface
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces yes, Telcor QML or Alere RALS
LOINC can be used to identify tests when communicating with LIS yes
Distinguishing features (supplied by company) smooth, durable sealed housing designed for hospital use that withstands cleaning, disinfecting, and penetration of liquid; 150 individual quality checks are conducted prior to measuring the glucose concentration, including test strip, meter, data, and dosing; patented dual-current AC/DC meter technology checks a wide range of variables including compensation for hematocrit; meter-level wireless technology for real-time data transfer without need of docking the meter; code key ensures lot-specific calibration to minimize bias for consistent, accurate results; extensive studies to prove system performance in the presence of potential interferences following CLSI guidelines; award-winning, live 24/7/365 customer care service and support
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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