Z-0741-2023Class II

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

Name: Z-0741-2023 InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA...
Creator: Companion Medical, Inc.
Published: 2022-11-08
License: https://open.fda.gov/license/

Companion Medical, Inc. / initiated 2022-11-08 / Open, Classified / root cause: software

FDA source

Companion Medical, Inc. began a recall of InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA... on 2022-11-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0741-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-08
Posted: 2022-12-20
Recalling firm: Companion Medical, Inc.
Product: InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Product code: NDC Calculator, Drug Dose
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0741-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0741-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-20

Product code NDC

K201337Class IIInPen SystemCompanion Medical, Inc. / cleared 2020-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)