Recall Z-0741-2023— Companion Medical, Inc.

Name: FDA recall Z-0741-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-08

Class II · Ongoing

Class II FDA medical device recall by Companion Medical, Inc., initiated 2022-11-08. It names one FDA 510(k) clearance: K201337. 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.. Reason: 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..

Recalling firm: Companion Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-08
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K201337 — InPen SystemCompanion Medical, Inc.·cleared 2020-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.