MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-31 for T:SLIM X2 INSULIN PUMP 1000354 1000353 manufactured by Tandem Diabetes Care.
[146820893]
Per the user guide: do not use any other insulin with your pump other than u-100 humalog? Or novolog?. Only humalog? And novolog? Have been tested and found to be compatible for use in the pump. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause very high or a very low blood glucose. No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[146820894]
It was reported that the customer experienced continuous elevated bg (300 mg/dl) and insulin injections were administered to address bg. Customer alleged pump was not delivering insulin properly. Customer thought pump may have possibly been exposed to moisture or dropped. Pump system check was performed with tandem technical support (cts) and no device issues were identified. Reportedly, admelog was used in the cartridge. Cts informed customer that admelog was not labeled for use with the pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013756811-2019-30063 |
| MDR Report Key | 8660193 |
| Report Source | CONSUMER |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2019-05-09 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2019-05-31 |
| 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 | JULIA KENSICK |
| Manufacturer Street | 11075 ROSELLE ST. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8583666900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T:SLIM X2 INSULIN PUMP |
| Generic Name | INSULIN PUMP |
| Product Code | LZG |
| Date Received | 2019-05-31 |
| Model Number | 1000354 |
| Catalog Number | 1000353 |
| 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 | 2019-05-31 |