Recall Weekly
Serious riskFDA DeviceClass I

Tandem Mobi insulin pumps recalled for false occlusion alarms

Tandem Diabetes Care found that some Tandem Mobi insulin pumps can give false occlusion alarms when no blockage is present. This can cause the pump to stop insulin delivery until the user acknowledges the alarm and restarts therapy. Repeated interruptions could lead to high blood glucose, and in severe cases may require medical care or hospitalization.

From the FDA notice · Read the official notice ↗ · All Tandem Diabetes Care recalls

What to do

  1. Check whether your Tandem Mobi pump model and serial number are on the recall list.
  2. Watch for occlusion alarms when you cannot find a blockage, and check your blood glucose if your pump stops delivering insulin.
  3. Contact Tandem Diabetes Care about a pump exchange if you have frequent false alarms.
  4. Ask your healthcare provider what backup insulin plan to use if your pump stops delivering insulin.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018077, 1018078
Sold in
Nationwide
Made for
Adults (under 100 years)

Details

Units affected
80,938 (77,559 US, 3,379 OUS)
Illnesses reported
None reported
Manufactured in
12400 High Bluff Dr, San Diego, California, United States
Classification
Class I
Recall number
Z-0316-2027

In the FDA's words

Description
Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018077, 1018078 Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigation determined that increased friction within the drive module can reduce available motor power and, under certain conditions, cause motor speed to fall below the occlusion detection threshold. As a result, the pump may incorrectly detect an occlusion condition and suspend insulin delivery. When an occlusion alarm occurs, insulin delivery remains suspended until the user acknowledges the alarm and resumes therapy. Repeated false-positive occlusion alarms, if not addressed promptly, may result in interruptions of insulin delivery that can increase the risk of elevated blood glucose levels. In severe cases, hyperglycemia may require medical intervention or hospitalization. UDI-DI: 00389152075013 00389152271910 00389152350110 00389152365510 00389152365619 00389152370019 00389152480114 00389152481111 00389152481319. All affected pump models and serial numbers may be affected. Pump serial numbers with frequent false-positive occlusion alarms to be exchanged: 1198599 1199144 1201048 1201777 1202107 1202156 1204500 1204935 1207112 1209405 1209862 1211585 1218143 1220121 1220201 1220470 1220471 1221343 1221347 1221775 1221783 1222111 1223346 1223487 1223488 1223886 1223906 1223940 1224363 1224978 1225017 1225024 1225158 1225171 1225194 1225204 1225589 1225602 1225682 1226359 1226360 1226365 1226671 1226721 1226748 1226859 1226989 1227008 1227021 1227227 1227375 1227442 1229300 1229807 1229969 1230064 1231839 1233326 1233515 1233517 1233562 1233617 1233665 1233701 1233711 1234069 1234080 1234136 1234188 1234240 1234244 1234521 1234597 1234601 1234703 1234715 1234717 1234718 1234732 1235069 1235124 1235131 1235132 1235138 1235193 1235195 1235204 1235335 1236661 1236815 1236825 1236879 1236945 1237266 1237283 1237337 1237722 1237727 1238064 1238085 1238466 1238517 1238533 1238538 1238742 1238801 1238806 1238820 1238851 1238882 1238899 1238923 1239003 1239011 1239016 1239048 1239054 1239057 1239058 1239094 1239104 1239120 1239489 1239496 1239518 1239527 1239560 1239756 1239762 1239794 1239812 1239814 1239815 1239845 1239877 1239884 1239885 1240021 1241967 1242353 1242365 1242366 1242374 1242450 1242747 1243800 1243835 1243889 1243922 1244195 1244451 1244847 1244896 1244921 1245188 1245997 1246094 1246395 1246498 1246814 1246822 1246899 1246929 1246944 1247002 1247051 1249794 1249801 1250108 1250151 1250360 1250526 1250661 1250662 1250719 1250729 1250755 1250787 1250790 1250791 1251854 1251877 1251883 1251894 1251899 1251911 1252132 1252137 1252302 1252408 1252418 1252427 1252498 1252506 1252509 1252522 1252529 1252536 1252674 1252676 1252687 1252712 1252718 1252726 1252941 1252951 1252976 1253001 1253036 1253048 1253061 1253095 1253210 1253214 1253217 1253248 1253286 1253314 1253327 1253343 1253344 1253378 1253639 1253653 1253725 1253740 1253741 1253743 1253753 1253760 1253765 1253801 1253829 1253830 1254011 1254126 1254150 1254153 1254203 1254205 1254278 1254291 1254303 1254481 1254484 1254551 1254561 1254598 1254640 1254653 1254672 1254674 1254805 1254835 1254840 1254853 1254951 1254965 1254977 1255025 1255054 1255116 1255117 1255179 1255183 1255219 1255287 1255296 1255355 1255383 1255386 1255399 1255436 1255472 1255473 1255540 1255547 1255648 1255653 1255657 1255729 1255730 1255762 1255858 1255948 1256065 1256185 1256186 1256209 1256219 1256246 1256264 1256385 1256407 1256435 1256438 1256497 1256538 1256541 1256552 1256607 1256609 1256627 1256690 1256694 1256696 1256711 1256754 1256757 1257039 1257103 1257122 1257125 1257139 1257218 1257320 1257324 1257391 1257401 1257415 1257460 1257472 1257540 1257550 1257567 1257597 1257794 1257818 1257824 1257966 1258073 1258094 1258238 1258288 1258302 1258325 1258359 1258360 1258367 1258380 1258407 1258554 1258613 1258621 1258640 1258649 1258654 1258674 1258689 1258721 1259005 1259009 1259082 1259084 1259159 1259226 1259233 1259236 1259291 1259322 1259342 1259354 1259671 1259700 1259836 1259850 1259856 1259864 1259871 1259887 1259895 1259897 1259926 1259930 1259996 1260001 1260017 1260067 1260070 1260131 1260492 1260523 1260625 1260647 1260749 1260868 1261043 1261074 1261344 1261346 1261350 1261383 1261389 1261456 1261463 1261468 1261475 1261506 1261521 1261531 1261535 1261696 1261746 1261747 1261837 1261843 1261926 1261933 1261994 1262009 1262029 1262037 1262048 1262084 1262085 1262124 1262160 1262232 1262249 1262381 1262397 1262399 1262402 1262403 1262409 1262482 1262609 1262619 1262625 1262626 1262629 1262648 1262663 1262846 1262944 1262997 1263008 1263077 1263096 1263204 1263226 1263234 1263240 1263265 1263280 1263297 1263353 1263395 1263469 1263499 1263500 12635
Hazard
Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigation determined that increased friction within the drive module can reduce available motor power and, under certain conditions, cause motor speed to fall below the occlusion detection threshold. As a result, the pump may incorrectly detect an occlusion condition and suspend insulin delivery. When an occlusion alarm occurs, insulin delivery remains suspended until the user acknowledges the alarm and resumes therapy. Repeated false-positive occlusion alarms, if not addressed promptly, may result in interruptions of insulin delivery that can increase the risk of elevated blood glucose levels. In severe cases, hyperglycemia may require medical intervention or hospitalization.

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