medical Class II Updated 2021-03-17

Insulet Corporation recalls Omnipod DASH Insulin Management System User Guide (OUS Only

Recalled Product

Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

Hazard / Issue

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

Issued by

FDA

Distribution: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

Lot/Code Info: Part Number/Rev./Country: PT 000002 AUT DEU mg 1, 2, 3 Guide, Dash User, German Austria PT 000002 BEL DEU MG 1, 2, 3 Guide, Dash User Guide, Belgium Germany, mgdl PT 000002 BEL FRE MG 1, 2, 3, 4 Guide, Dash User Guide, Belgium French, mgdl PT 000002 BEL NLD MG 1, 2, 3 Guide, Dash User Guide, Belgium Dutch, mgdl PT 000002 DEU DEU mg 1, 2, 3 Guide, Dash User Guide, German Germany, mgdl PT 000002 DEU DEU mm 1, 2, 3 Guide, Dash User Guide, German Germany, mmoll PT 000002 DNK DANmm 1, 2, 3 Guide, Dash User Guide, Danish Denmark PT 000002 FIN FIN mm 1, 2, 3 Guide, Dash User Guide, Finnish Finland PT 000002 FRA FRE mg 1, 2, 3, 4 Guide, Dash User Guide, French France PT 000002 NLD NLD mm 1, 2, 3, 4 Guide, Dash User Guide, Dutch Netherland PT 000002 NOR NORmm 1, 2, 3 Guide, Dash User Guide, Norwegian Norway PT 000002 SWE SWEmm 1, 2, 3 Guide, Dash User Guide, Swedish Sweden 41333 CAN 1, 2 User Guide, Omnipod, Dash, Canada PT 000318 1, 2 Guide, Dash User Guide, Greece PT 000319 1, 2 Guide, Dash User Guide, Turkey

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