FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 7232673
·
Received January 31, 2018
Report
- Report Number
- 3013756811-2018-02293
- Event Type
- Malfunction
- Date Received
- January 31, 2018
- Date of Event
- November 8, 2017
- Report Date
- January 31, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP BATTERY WAS OBSERVED TO BE DEPLETING QUICKLY. THE CUSTOMER REPORTED THE BATTERY DEPLETED 80% WITHIN ONE DAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180-272 (MG/DL). REPORTEDLY THE CUSTOMER WOULD CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74245 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |