FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8620146
·
Received May 17, 2019
Report
- Report Number
- 3013756811-2019-26304
- Event Type
- Malfunction
- Date Received
- May 17, 2019
- Date of Event
- April 26, 2019
- Report Date
- May 17, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007301
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER THE USER GUIDE: NEVER FILL YOUR TUBING WHILE YOUR INFUSION SET IS CONNECTED TO YOUR BODY. ALWAYS ENSURE THAT THE INFUSION SET IS DISCONNECTED FROM YOUR BODY BEFORE FILLING THE TUBING. FAILURE TO DISCONNECT YOUR INFUSION SET FROM YOUR BODY BEFORE FILLING THE TUBING CAN RESULT IN OVER DELIVERY OF INSULIN. 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 CUSTOMER PERFORMED THE LOAD FILL TUBING SEQUENCE WHILE CONNECTED AT THE SITE. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 132-142 MG/DL. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER AGAINST PERFORMING THE FILL TUBING SEQUENCE WHILE CONNECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414599 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |