Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software Version 1.0.50 and earlier Lots L000120 L000121 L000122 L000123 L000124 L000125 L000126 L000127 L000128 L000129 L000130 L000131 L000132 L000133 L000134 L000135 L000136 L000137 L000138 L000139 L000140 L000141 L000142 L000143 L000144 L000145 L000146 L000147 L000148 L000149 L000150 L000151 L000152 L000153 L000154 L000155 L000156 L000157 L000158 L000159 L000160 L000161 L000162 L000163 L000164 L000165 L000166 L000167 L000168 L000169 L000170 L000171 L000172 L000173 L000174 L000175 L000176 L000177 L000178 L000179 L000180 L000181 L000182 L000183 L000184 L000185 L000186 L000187 L000188 L000189 L000190 L000191 L000192 L000193 L000194 L000195 L000196 L000197 L000198 L000199 L000213 L000214 L000204
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Insulet Corporation
- Reason for Recall:
- In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
Product Codes/Lot Numbers:
Software Version 1.0.50 and earlier Lots L000120 L000121 L000122 L000123 L000124 L000125 L000126 L000127 L000128 L000129 L000130 L000131 L000132 L000133 L000134 L000135 L000136 L000137 L000138 L000139 L000140 L000141 L000142 L000143 L000144 L000145 L000146 L000147 L000148 L000149 L000150 L000151 L000152 L000153 L000154 L000155 L000156 L000157 L000158 L000159 L000160 L000161 L000162 L000163 L000164 L000165 L000166 L000167 L000168 L000169 L000170 L000171 L000172 L000173 L000174 L000175 L000176 L000177 L000178 L000179 L000180 L000181 L000182 L000183 L000184 L000185 L000186 L000187 L000188 L000189 L000190 L000191 L000192 L000193 L000194 L000195 L000196 L000197 L000198 L000199 L000213 L000214 L000204
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1553-2020
Related Recalls
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.