Important Safety Notice
Rare cases have been identified where the Accu-Chek@ Aviva Combo or Accu-Chek@ Performa Combo blood glucose meter’s bolus advisor function may recommend a correction bolus amount less than intended.
This issue only occurs when a user confirms delivery of a “Manual Pump” bolus on the blood glucose meter and does not complete the task of delivering the bolus manually via the pump, or delivers a bolus amount manually via the pump that differs from the amount entered on the meter.
Prevention and Safety Measures
Users are advised to always deliver the exact bolus amount, as entered in the blood glucose meter, manually on the pump within 10 minutes, and to closely monitor their blood glucose for indications of high blood glucose (hyperglycemia) and administer insulin appropriately to correct it.
The Accu-Chek@ Combo System can be used safely and reliably if used as directed, and users are not limited in the safe and reliable manual operation of the pump if they take into account and avoid the above-described aspects.
Manual:
Download: URGENT FIELD SAFETY NOTICE for Accu-Chek@ Aviva Combo Meter and Accu-Chek@ Performa Combo Meter
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