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

FDA device recall Z-0741-2023 · posted 2022-12-20 · Open, Classified

Recall details

Recalling firm

Companion Medical, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

NDC

Quantity affected

140

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.

Date initiated

2022-11-08

Date posted

2022-12-20

Location

San Diego, CA

Related 510(k) clearances