Recall Z-1562-2020 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom Inc
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
| Date | Feb 3, 2020 |
| Status | Terminated |
| Reason | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. |
| Root cause | Under Investigation by firm |
| Action | Starting in February 2020, the firm will add an "URGENT MEDICAL DEVICE CORRECTION" Notification to sensor packaging informing valued customers that the firm recently became aware that hydroxyurea, an anti-neoplastic drug used primarily in chemotherapy, falsely elevates glucose readings on its Continuous Glucose Monitoring (CGM) Systems. This may result in failure to treat hypoglycemia from missed low sensor glucose values and alerts or by causing other errors in diabetes management decisions (for example, hypoglycemia resulting from an insulin dose based on a falsely elevated sensor glucose re |
| Quantity | 275583 |
| Distribution | World-wide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexco Dexcom, Inc., Jun 28, 2019 |