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 INTEROPERABLE TECHNOLOGY 1000096 1000886 manufactured by Tandem Diabetes Care.
[186853510]
The tandem user guide states: do not use any other insulin with your system other than u-100 humalog or novolog. Only humalog and novolog have been tested and found to be compatible for use in the system. 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
[186853511]
It was reported that multiple intermittent occlusion alarms occurred. Reportedly, customer was using fiasp insulin. Tandem technical support educated customer regarding cartridge/insulin labeling. Customer's blood glucose level was 450 mg/dl. Reportedly, the pump supplies were changed to address the issue however, customer reverted to manual injections for insulin therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013756811-2020-33781 |
| MDR Report Key | 9904328 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-02-01 |
| 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 INTEROPERABLE TECHNOLOGY |
| Generic Name | ALTERNATE CONTROLLER ENABLED INFUSION PUMP |
| Product Code | QFG |
| Date Received | 2020-03-31 |
| Model Number | 1000096 |
| Catalog Number | 1000886 |
| 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 |