MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for T:SLIM INSULIN DELIVERY SYSTEM 004628 007262 manufactured by Tandem Diabetes Care.
[187692424]
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[187692425]
It was reported that the insulin gauge was inaccurate. Additionally, it was reported that the pump battery was depleting quickly. There was no reported impact to the customer? S blood glucose level. Customer declined troubleshooting with tandem technical support and declined to provide further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013756811-2020-30483 |
| MDR Report Key | 9908425 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-04-01 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MICK TRIER |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584011451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T:SLIM INSULIN DELIVERY SYSTEM |
| Generic Name | INSULIN PUMP |
| Product Code | LZG |
| Date Received | 2020-03-31 |
| Model Number | 004628 |
| Catalog Number | 007262 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TANDEM DIABETES CARE |
| Manufacturer Address | 11075 ROSELLE STREET SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |