MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY 1000096 1000886 manufactured by Tandem Diabetes Care.
[187264519]
The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be filed upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[187264520]
It was reported that an unexpected reset occurred. Additionally, it was reported that the pump touch screen was unresponsive. The customer reverted to manual injections for insulin therapy. Customer's blood glucose was 150 mg/dl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013756811-2020-30371 |
| MDR Report Key | 9908411 |
| Report Source | CONSUMER |
| 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 | 2019-09-01 |
| 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 X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY |
| Generic Name | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND |
| Product Code | OZO |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-24 |
| Model Number | 1000096 |
| Catalog Number | 1000886 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |