Recall record at a glance
| Official record | Z-1501-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medtronic MiniMed Inc. |
| Report date | Apr 27, 2016 |
| Recall initiation date | Feb 19, 2016 |
| Quantity | 20 |
| Location | Northridge, CA, United States |
Official product description
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Why the product was recalled
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
Distribution information
US: MN
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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