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U.S. Department of Health and Human Services

Class 2 Device Recall Omnipod DASH Personal Diabetes Manager (PDM)

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  Class 2 Device Recall Omnipod DASH Personal Diabetes Manager (PDM) see related information
Date Initiated by Firm February 13, 2020
Create Date March 20, 2020
Recall Status1 Terminated 3 on September 14, 2021
Recall Number Z-1553-2020
Recall Event ID 84982
510(K)Number K192659  
Product Classification Pump, infusion, insulin - Product Code LZG
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).
Code Information 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 
Recalling Firm/
Manufacturer		 Insulet Corporation
100 Nagog Park
Acton MA 01720-3440
For Additional Information Contact Customer Service
800-581-6359
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action On February 14, 2020, the firm notified all affected customers of the recall via Urgent Medical Device Correction letters through email and post; the customer communication was also posted on the firm's website. Customers were informed of the product issue and provided with the following precautions: 1. Always enter a current BG into the Bolus Calculator before giving a bolus. This will replace the old BG value and ensure an accurate dose is calculated based on the current BG. 2. Total Bolus should always be the sum of the Meal Bolus and Correction Bolus. The firm will be making a software update to the next version of Omnipod DASH PDM which will provide a solution for this issue and is expected to be available starting March 2020. The firm will be voluntarily providing a replacement PDM to all existing Omnipod DASH users. The firm will contact users directly when replacements are ready to be shipped. Customers may visit www.omnipod.com for updated information on PDM replacement timing. In the meantime, the firm states that customers may continue using their current Omnipod DASH PDM provided you follow the above precautions. If you have any questions regarding the information provided in this Medical Device Correction, please contact 1-800-581-6359.
Quantity in Commerce 32756 (US), 1420 (International)
Distribution US Nationwide distribution. Foreign distribution to Italy, Netherlands, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = Insulet Corporation
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