Device product
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Z-1601-2021
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 87476
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,224,032 units
- Official record key
device-enforcement:Z-1601-2021
Official wording
Reason: Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Code information: All Lot numbers within active shelf life
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.