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Abbott Diabetes Care, Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System (BedsideGlucose_2018)

Abbott Diabetes Care, Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System (BedsideGlucose_2018)

Bedside glucose testing systems, April 2018

Contact Information

Abbott Diabetes Care
Alameda, CA
877-643-2098


Name of instrument/First year sold Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System/2014
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 length: 7.85 inches ±.08; width: 2.93 inches ±.08; thickness: 1.92 inches ±.08/10.58 oz ±.51
Analytical method or technology or enzyme system used glucose-specific GDH-NAD enzyme and low applied voltage to minimize interference; β-hydroxybutyrate, the predominant blood ketone associated with DKA
No. of disposable reagent system units per basic package glucose: 100 individually wrapped strips; ketone: 50 individually wrapped strips
Disposable units shelf life/Reagent unit storage requirements 18 months/39°–86°F (4°–30°C)
Digital readout character size/Keypad input capability character size varies/alphanumeric keypad
How results are displayed plasma equivalent glucose values
Specimen types/Sampling techniques glucose and ketone: fresh capillary, venous, arterial, or neonatal whole blood/top-fill or end-fill sample application
Minimum specimen volume required glucose: 0.6 μL; ketone: 1.5 μL
Suitable for samples from well neonates/Sick neonates yes/yes
Time from sample introduction to result availability glucose: 5 seconds; ketone: 10 seconds
Batteries used/No. used/Average life of one set of batteries AA alkaline, lithium, nickel cadmium, or NiMH rechargeable/depends on type/depends on use
Average expected life of device/Mean time between failures
Device warranty/Service options/Loaners provided 1 year or contract term/replacement/no
User list or user group
Toll-free No. for customer questions/Hours of operation 877-529-7185/24 hours, 7 days, all year
Training and certification program/No. of training days provided yes/based on implementation plan
Average time for lab to complete maintenance no maintenance required
Internal QC recommended or required as defined by facility or institutional policy
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 blood glucose results: 100% within ±15 mg/dL or ±15%; 95.1% within ±10 mg/dL or ±10%/YSI glucose analyzer
Precision/Compared with what reference method or device repeatability: pooled whole blood SD 2.8 mg/dL at concentrations <75 mg/dL and <3.6% CV for concentrations ≥75 mg/dL; intermediate precision: pooled whole blood SD 2.8 mg/dL at concentrations <75 mg/dL and <5.0% for concentrations ≥75 mg/dL
Linear range glucose: 20–500 mg/dL; ketone: 0.0–8.0 mmol/L
Suggested dynamic or measurement range glucose: 20–500 mg/dL; ketone: 0.0–8.0 mmol/L
Contraindications per labeling
Known interferences/High-altitude interference per labeling/no (tested up to 7,200 ft)
Restrictions based on hematocrit hematocrit range: 15–65%
Electronic and optical function checks battery, barcode scanner, database, and temperature checks performed during power-up
Sample quantity checks test strip contains fill-trigger electrode designed to start the test when sufficient sample is detected
When auto lock or shutdown occurs configurable lockout for operator certification, strip lot, upload and QC requirements
User defines QC lockout intervals/QC lockout can be circumvented yes/no
Information for which device supports barcode scanning operator ID, patient ID, strip lot, QC, comment code, and free text field data
Method of analyst ID/ID required scan or manual entry/required
Internal memory size/Maximum No. of patient results stored patient test results: 2,500; control test results: 1,000; patient IDs: 6,000; operator IDs: 6,000; test strip lots: 36 (18 glucose, 18 ketone)
Meter connections for information transfer data-management system, which in turn connects to LIS/HIS
How meters are connected to external system to upload results wireless data transfer post test or via docking station connected to ethernet
Information contained in transmission to external system device unique identifier, operator ID, patient ID, reagent and QC lot numbers, test results, comment codes, and free text entry
Hardware/software for data-management system compatible with data-management systems from Abbott, Alere, Siemens, and Telcor
No. of different management reports system can produce depends on data-management system
Contents downloaded from DMS to meter operator list, patient list, strip lot list, adjusted QC ranges, and meter configuration settings
LISs/HISs to which system is connected (live installs) using:
• Screen animation/Screen scraping
• Standard HL7 interface
• Proprietary protocol interface
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces via Siemens, Telcor, or Alere
LOINC can be used to identify tests when communicating with LIS yes
Distinguishing features (supplied by company) individually foil-wrapped test strips support a no-touch procedure and vial-free solution, which assists in complying with CDC and CLSI recommendations; 1D/2D barcode reader; real-time dual band wireless data transmission; TrueID technology with active patient ID confirmation, which assists in complying with the Joint Commission’s NPSG.01.01.01; replaceable strip port module
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.