MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for T:CONNECT manufactured by Tandem Diabetes Care, Inc..
[137131613]
The print out from the website program (t:connect) for the tandem pump was completely inaccurate. If trying to make pump adjustments based on the data from the printout, it could cause significant issues. The printout stated that the patient was using 931 units of insulin per day when he was actually using 32 units of insulin per day; it said he was consuming over 1,000 grams of carbs per day when he was consuming closer to 100 grams. All of the findings on the tandem report were completely wrong compared to what was actually happening with the patient. I could provide printouts of both.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084109 |
| MDR Report Key | 8343607 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-11 |
| Date Added to Maude | 2019-02-15 |
| 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 |
| 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:CONNECT |
| Generic Name | MEDICAL DEVICE DATA SYSTEM |
| Product Code | OUG |
| Date Received | 2019-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TANDEM DIABETES CARE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-14 |