InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA
Summary
The FDA issued a Class II for InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT by Companion Medical, Inc.. 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 inabi.
Details
Source
Device Recall
External ID
Z-0741-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 140
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-08
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Companion Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Companion Medical, Inc. have FDA actions?
This is the only FDA action we have on record for Companion Medical, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0741-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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