|
Class 2 Device Recall Guardian 4 Sensor |
|
Date Initiated by Firm |
November 15, 2023 |
Date Posted |
February 07, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1005-2024 |
Recall Event ID |
93675 |
PMA Number |
P160017S091 |
Product Classification |
Automated insulin dosing device system, single hormonal control - Product Code OZP
|
Product |
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
|
Code Information |
REF/UDI-DI/Lot: MMT-7040A/20763000413389/HG72B2C, HG72CQQ, HG73VB7, HG73VC8, HG73VFT, HG73WFR, HG7441E, HG745F9, HG7486X, HG74AJ1, HG74SUR, HG74T9Q, HG74U36, HG78LMS, HG79Y9U;
MMT-7040C1/00763000555276, 00763000413392, 20763000413396, 20763000555270, 20763000712475, 00763000712471/F1323, F1923, G0323, G1723, G2023, G2623, G2923, HG6RV7S, HG6TGNU, HG6TJ2Y, HG6TW97, HG6TWVU, HG6UNF2, HG6V8NN, HG6VB8S, HG6VNX3, HG6WNE1, HG6XFPR, HG6XH54, HG6XQCG, HG6XZJX, HG6Y0W1, HG6Y3QN, HG6YEK6, HG6YFAF, HG6YFHL, HG6YJAR, HG6YJBD, HG6YNGD, HG6Z7N5, HG6ZARN, HG7038Y, HG70CW5, HG70DAM, HG70JSU, HG70LRC, HG70QWA, HG71VMZ, HG72DB5, HG72G9C, HG72NV9, HG72R1P, HG72RBD, HG72SE3, HG72TPT, HG72TRV, HG72V3J, HG72ZFP, HG7340A, HG73EJX, HG73RNR, HG745SV, HG747E3, HG7480Q, HG749N6, HG74F93, HG75TSX, HG75XA1, HG76HFH, HG76RYY;
MMT-7040C2/20763000555287/HG6RC39, HG6RXB5, HG6T4T7, HG6T8RV, HG6TJ2Y, HG6WKZU, HG6WLKS, HG6XFPR, HG6XH54, HG6XLSD, HG6XNH3, HG6Y5C6, HG6Z1X5, HG713AK, HG73EGX, HG73EJX, HG73FJP, HG73Q24, HG73QPM, HG73RNR, HG7619X, HG764J9, HG76CWC, HG77FMK;
MMT-7040C3/20763000555294/HG6XNH3, HG73RNR;
MMT-7040D1/00763000413484/HG6THY1, HG6V7VV;
MMT-7040D2/00763000413491/HG6TL44;
MMT-7040MA/20763000519692/HG74460;
MMT-7040QC1/00763000555313, 20763000555317/HG6WT9A, HG6WUGE, HG73PH3;
MMT-7040QC2/20763000555324, 763000555320/HG6WT9A;
MMT-7040QC3/20763000555331/HG6WT9A
|
Recalling Firm/ Manufacturer |
Medtronic MiniMed, Inc. 18000 Devonshire St Northridge CA 91325-1219
|
For Additional Information Contact |
Medtronic 24-Hr Technical Support 800-646-4633
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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 return the confirmation form via email to rs.safetyinformation@medtronic.com
Distributors were asked to either 1) notify impacted customers using the Correction Letter and provide status updates to the recalling firm regarding customer responses, or 2) provide the recalling firm with customer addresses so they can notify impacted customers.
If you have any questions, please contact the firm at 800-646-4633, option 1.
|
Quantity in Commerce |
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, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Liechtenstein, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
|
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
PMA Database |
PMAs with Product Code = OZP and Original Applicant = MEDTRONIC MINIMED, INC.
|
|
|
|