Skip to content

InPen Smart Insulin Delivery System recallZ-0741-2023 · Companion Medical, Inc. · initiated Nov 8, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Companion Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.

FDA root cause category: Software design

What the company is doing

On 11/8/22, Medtronic emailed correction notices to customers who were asked to do the following: 1) Verify the running app by: a) Open the app on the device, b) From Home screen tap the "Settings" button, c) Select the "Help and Support" option, d) Under Contact Us section, note the app version listed. 2) If affected app versions are not listed, no action is necessary. 3) If affected apps are listed, uninstall the app and reinstall the version currently available in the app store (5.5.4.4) by following these steps: a) Perform an app search for InPen, b) Tap the icon to the left of the Open button, c) Tap the Uninstall button, d) Confirm the uninstall, e) Tap the Install button. 4) After reinstall and log into the InPen app all past data will remain available and visible within the app logbook. 5) Acknowledge receipt and understanding of the correction notice. The firm provided the following 24-hour technical support phone number: 1-800-646-4633, option 1.

Recall details

Recall number
Z-0741-2023
Status
Open, Classified
Initiated by the company
Nov 8, 2022
Posted by the FDA
Dec 20, 2022
Recalling firm
Companion Medical, Inc.
Quantity
140
Product code
NDC
FDA submissions
K201337
Distribution
US Nationwide distribution including in the states of CA, NY, MT, OH, IN, MN, PA, CT, TX, WA, TN, SD, MI, FL, OR, NC, KY, WI, MO, WV, NV, SC, AZ, AR, MA, LA, VT, GA.

Product description

InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.

Code information (models, lots, serial numbers)

InPen Software App for Android, versions 5.6.1.1 and 5.6.2 with InPen System REF/UDI-DI: MMT-105ELBLNA/10862088000313, MMT-105ELGYNA/10862088000320, MMT-105ELPKNA/10862088000337, MMT-105NNBLNA/10862088000344, MMT-105NNGYNA/10862088000351, MMT-105NNPKNA/10862088000368.

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K201337 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page