MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for DEXCOM CGM - FOLLOW APP manufactured by Dexcom Inc..
[137995689]
Dexcom follow app , when checking my son? S blood sugar history to give an insulin correction, the history showed incorrect times associated with his sugar levels, causing it to appear less insulin was on board, causing too much insulin to be administered as a correction. Dexcom follow app. Choose the 6hr, 12hr, 24hr view. The times are incorrect and do not match the blood sugar history. Follow app - bug in update.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084646 |
| MDR Report Key | 8392333 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-03-03 |
| Date Added to Maude | 2019-03-05 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | DEXCOM CGM - FOLLOW APP |
| Generic Name | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FOR NON INTENSIVE DIABETES MANG |
| Product Code | QDK |
| Date Received | 2019-03-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEXCOM INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-05 |