MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for CARELINK PERSONAL SOFTWARE manufactured by Medtronic Minimed.
[126219599]
Pt reported that he is unable to upload data from his glucose monitoring system to his physician. There is a software issue with the device stated pt. Pt called mfr to report issue and was told they are aware of the issue with the device and they have not resolved the issue as of date. Pt stated medtronic is unable to update the software system of the device on time. Pt stated he wants fda to have stricter requirements for mfr's that use software systems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081002 |
| MDR Report Key | 8032496 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-09-30 |
| Date Added to Maude | 2018-11-02 |
| 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 PERSONAL SOFTWARE |
| Generic Name | CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE |
| Product Code | PHV |
| Date Received | 2018-11-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MINIMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-01 |