Insulet recalls Omnipod DASH insulin management system user guides with a misprint that could cause incorrect insulin doses and hypoglycemia for users outside the US. Affected guides include specific language versions sold in Canada, Germany, France, and other countries.
Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended
Insulet is recalling user guides for the Omnipod DASH insulin management system that contain a misprint. This error could lead to incorrect insulin doses if users mistakenly use a period instead of a comma for decimal separators, potentially causing hypoglycemia.
The user guide mistakenly states that a comma is not used for decimals on the PDM, when in fact a period is the correct separator. If users enter insulin doses using a period as a decimal, the device may not recognize the value correctly, leading to higher doses than intended and potential hypoglycemia.
Users outside the US who have the Omnipod DASH system with the specific user guides listed in the recall (e.g., German, French, Dutch versions sold in Canada, Germany, France, and other countries). People using these guides without correcting the decimal separator error are at risk of hypoglycemia.
Check if you have the Omnipod DASH user guide with the product catalog number PT 000002 in the following countries: Canada, Germany, France, Belgium, Netherlands, Austria, Sweden, Norway, Denmark, Finland, Turkey, and Greece. The guide may be in German, French, Dutch, or other languages as specified.
Verify your Omnipod DASH user guide has the product catalog number PT 000002 and matches the country-specific language version listed in the recall.
The user guide contains a misprint that could lead to incorrect insulin doses if users mistakenly use a period instead of a comma for decimal separators, potentially causing hypoglycemia.
The recall affects users in Canada, Germany, France, Belgium, Netherlands, Austria, Sweden, Norway, Denmark, Finland, Turkey, and Greece.
Check for the product catalog number PT 000002 on the user guide and verify the country-specific language version (e.g., German, French, Dutch) as listed in the recall.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-1203-2021 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-1203-2021 from Insulet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
