FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 8359007
·
Received February 21, 2019
Report
- Report Number
- 3013756811-2019-08509
- Event Type
- Malfunction
- Date Received
- February 21, 2019
- Date of Event
- January 29, 2019
- Report Date
- February 21, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004781
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
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 INTERMITTENTLY OBSERVED TO BE DEPLETING RAPIDLY, WHICH LED TO INTERMITTENT PUMP SHUTDOWNS. THE CUSTOMER PROVIDED A BLOOD GLUCOSE RANGE OF 172-203 MG/DL. TANDEM TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO CHARGE THE PUMP COMPLETELY AND MONITOR THE BATTERY PERFORMANCE. CUSTOMER ACKNOWLEDGED. UPON FOLLOW UP, THE CUSTOMER INDICATED THAT THE BATTERY DEPLETION RATE WAS WITHIN NORMAL PARAMETERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153034 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |