MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for T:SLIM G4 PUMP manufactured by Tandem Diabetes Care, Inc..
[106835745]
For the last 2 months insulin pump quits displaying blood sugar. I have contacted tandem diabetes the pump maker who blames the issue on dexcom the sensor/transmitter maker who i have contacted and they say it is the pump. In defense of dexcom i have changed their products which are the disposables. There is no resolve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076759 |
| MDR Report Key | 7464220 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-23 |
| Date Added to Maude | 2018-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | T:SLIM G4 PUMP |
| Generic Name | PUMP, INFUSION, INSULIN, TO BE USED W/ INVASIVE GLUCOSE SENSOR |
| Product Code | OYZ |
| Date Received | 2018-04-25 |
| Model Number | G4 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TANDEM DIABETES CARE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-25 |