Model note · Glucometer
Roche Accu-Chek Inform II
The Accu-Chek Inform II is a hospital point of care blood glucose meter for multiple patient use by ward staff, measuring capillary, venous, arterial and neonatal heel stick whole blood. It is distinctive for its managed workflow: operator and patient ID by barcode, enforced quality control lockouts, and wireless links to a data management system so results and operator certification are tracked centrally.
The model
Maker, model and type.
- Maker
- Roche Diagnostics
- Model
- Accu-Chek Inform II
- Device type
- Glucometer
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Method | Amperometric electrochemical biosensor using a mutant quinoprotein glucose dehydrogenase (Mut. Q-GDH) with reduced maltose reactivity | Source |
| Measuring range | 10 to 600 mg/dL | Source |
| Measuring time | 5 seconds | Source |
| Sample volume | 0.6 microlitres | Source |
| Sample types | Capillary (fingertip), venous, arterial and neonatal heel stick whole blood; not neonatal cord blood | Source |
| Haematocrit range | 10 to 65% | Source |
| Traceability | Traceable to NIST SRM 917; compared against a hexokinase laboratory method | Source |
| Quality control materials | Two level controls and a six level linearity kit (about 28 to 559 mg/dL) | Source |
| Data entry | Touchscreen and/or 2D barcode reader for user ID, patient ID, password and strip and control lot numbers | Source |
| FDA clearance | K121679, 21 CFR 862.1345, product code NBW, decided 11 October 2012 | Source |
Recalls
Known FDA recalls.
- Z-2354-20212021-07-28
Strip vials (05942891001) could open inside sealed cartons in transit, exposing strips to humidity and inaccurate results.
FDA record - Z-2187-20182018-05-07
Two out of specification strip lots with more strip errors, undetected strips or possible undetectable bias.
FDA record - Z-1172-20162016-02-11
Base unit transmission errors could lose data or mismatch patient data in the data management system.
FDA record - Z-1113-20132013-03-06
Barcode reading meters could intermittently misdecode substandard patient ID barcodes.
FDA record
Safety
Safety warnings from the record.
- FDA labelling says results may be wrong in severe dehydration, hypotension, shock, NYHA class IV heart failure or peripheral arterial occlusive disease. Source
- Not for diagnosing or screening diabetes, and not for neonatal cord blood. Source
- Use only single use, auto disabling lancing devices, because the meter is shared between patients. Source
- Never spray into the strip port; moisture there can produce wrong glucose results. Do not spray the base unit or a meter sitting in it. Source
- Clean only with mild soap, up to 70% isopropyl alcohol or up to 0.625% sodium hypochlorite; avoid ether, polyhexanide and bleach plus detergent wipes. Source
Sources
Where this note comes from.
- Roche Accu-Chek Inform II system product page
- FDA decision summary K121679, Accu-Chek Inform II
- Roche Accu-Chek Inform II quick reference guide v6 (Czech, 2017)
- openFDA MAUDE problem counts, Accu-Chek Inform II
- openFDA recall search, Accu-Chek Inform II
Not covered: The full English operator manual, which holds the numbered error message table, is only on Roche's login portal or third party mirrors that refused access, so errorCodes is left empty. Meter dimensions, battery and memory specs were not confirmed from an official source. The FDA summary states performance was not evaluated in the critically ill; any later clearance for that population was not checked.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Glucometer