Recall Z-1005-2024 · OZP Automated Insulin Dosing Device System, Single Hormonal Control

Medtronic MiniMed, Inc.

Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3

Date	Feb 7, 2024 (initiated Nov 15, 2023)
Status	Open, Classified
Reason	Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.
Root cause	Process change control
Action	On 11/15/23, recall notices were mailed or emailed to patients, distributors, and healthcare professionals who were told the following: 1) If you have affected devices discard and contact the firm to receive replacement sensors in the following ways: by completing the web form at medtronicdiabetes.com/G4S-form, contacting 24-Hour Technical Support at 800-646-4633, option 1, or email rs.customerexperience@medtronic.com. 2) If you cannot identify the LOT number of the sensor you are currently wearing, remove the sensor and replace your sensor with a non-impacted sensor. 3) Please complete and
Quantity	114,758
Distribution	Worldwide - US Nationwide distribution including in the states of PR, AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Austria, Belgium, Cana
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.