Recall Z-1203-2021 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
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
| Date | Feb 1, 2021 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Labeling design |
| Action | Insulet issued Email, mail, or outbound call notification of the Field Safety Notification between Feb 2nd and Feb 5 th to end customers, HCPs and distributors in: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland. Letter states reason for correction, health risk and action to take: Please refer to the attached Annex in reference to page 6 of the User Guide as opposed to referring to the instructions in the existing User Guide. We recommend you place this insert at p.6 in your User Guide. Please ensure that the comma |
| Quantity | 21,723 guides |
| Distribution | Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation, Oct 21, 2019 |