MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for CARELINK manufactured by Medtronic.
[101019284]
The medtronic carelink software is not correctly recording blood glucose values and is, therefore, incorrectly reporting results. Since the reports from this are used by drs, nurses, pts, etc. , to manage their insulin pump and diabetes. It is impacting quality of care of diabetes management. My results are based on my personal diabetes data that i upload regularly to the medtronic carelink system. Then, my dr and i use the reports from the system to determine diabetes care management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075499 |
| MDR Report Key | 7295866 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-08 |
| Date Added to Maude | 2018-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARELINK |
| Generic Name | CARELINK |
| Product Code | PHV |
| Date Received | 2018-02-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |