medical Class II Updated 2020-04-01

Insulet Corporation recalls Omnipod DASH Personal Diabetes Manager (PDM), Catalog number

Recalled Product

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).

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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